<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT02257918</url>
  </required_header>
  <id_info>
    <org_study_id>14-0014</org_study_id>
    <secondary_id>HHSN272201300012I</secondary_id>
    <nct_id>NCT02257918</nct_id>
  </id_info>
  <brief_title>Randomized, Open-label Phase 2 Study of Oral AZD0914 in the Treatment of Gonorrhea</brief_title>
  <official_title>A Randomized, Open-label Phase 2 Study to Evaluate the Efficacy and Safety of a Single Dose of Oral AZD0914 Compared to Intramuscular Ceftriaxone in the Treatment of Male and Female Subjects With Uncomplicated Gonorrhea</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National Institute of Allergy and Infectious Diseases (NIAID)</source>
  <oversight_info>
    <is_fda_regulated_drug>Yes</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male&#xD;
      and female subjects, between the ages of 18 and 55, who are in good health and meet all&#xD;
      eligibility criteria. The study is designed to assess the safety and efficacy of an&#xD;
      antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to&#xD;
      adults to treat uncomplicated urogenital gonorrhea compared to treatment with ceftriaxone.&#xD;
      Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of&#xD;
      AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The drug name is&#xD;
      also known as ETX0914.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Uncomplicated gonorrhea is currently the second most common bacterial sexually transmitted&#xD;
      infection (STI) worldwide and, accordingly, is a serious public health problem. This is a&#xD;
      multi-center Phase 2 randomized, open-label study in approximately 180 adult male and female&#xD;
      subjects, between the ages of 18 and 55, with uncomplicated cervical or urethral gonorrhea.&#xD;
      The study is designed to assess the safety and efficacy of an antimicrobial investigational&#xD;
      product, AZD0914 manufactured by AstraZeneca, administered to adults to treat uncomplicated&#xD;
      urogenital gonorrhea compared to treatment with intramuscular ceftriaxone. Subjects will be&#xD;
      randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of AZD0914, 3000 mg of&#xD;
      AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The study duration is 11 months and&#xD;
      subject participation of 30 days. Subjects with 1) untreated urethral or cervical gonorrhea&#xD;
      identified via laboratory testing at a prior visit, or 2) untreated subjects acknowledging&#xD;
      anal, oral, or vaginal sexual contact in the past 14 days with someone diagnosed with&#xD;
      gonorrhea, or 3) signs and symptoms of urethral or cervical gonorrhea will be offered&#xD;
      enrollment in the study and consented. The primary objective assess the efficacy by&#xD;
      microbiological cure rate of 2000 mg or 3000 mg AZD0914 compared to 500 mg ceftriaxone for&#xD;
      the treatment of uncomplicated urogenital gonorrhea. The second primary objective assess the&#xD;
      safety and tolerability of a single oral dose of 200 mg or 3000 mg AZD0914 compared to 500 mg&#xD;
      ceftriaxone in adult subjects with uncomplicated urogenital gonorrhea. The drug name is also&#xD;
      known as ETX0914.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 25, 2014</start_date>
  <completion_date type="Actual">December 30, 2015</completion_date>
  <primary_completion_date type="Actual">December 30, 2015</primary_completion_date>
  <phase>Phase 2</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
  </study_design_info>
  <primary_outcome>
    <measure>Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm</measure>
    <time_frame>Day 6</time_frame>
    <description>Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.</measure>
    <time_frame>Day 1 through Day 31</time_frame>
    <description>Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm</measure>
    <time_frame>Day 6</time_frame>
    <description>Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm</measure>
    <time_frame>Day 6</time_frame>
    <description>Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With Clinical Cure in Each Study Arm</measure>
    <time_frame>Day 6</time_frame>
    <description>A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator's assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator's assessment was the final adjudicator.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.</measure>
    <time_frame>Day 1 (Baseline)</time_frame>
    <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.</measure>
    <time_frame>Day 6</time_frame>
    <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm</measure>
    <time_frame>Baseline and Day 6</time_frame>
    <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm</measure>
    <time_frame>Baseline and Day 6</time_frame>
    <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline</measure>
    <time_frame>Day 1 (Baseline)</time_frame>
    <description>For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6</measure>
    <time_frame>Day 6</time_frame>
    <description>For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline</measure>
    <time_frame>Day 1 (Baseline)</time_frame>
    <description>For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Day 6</measure>
    <time_frame>Day 6</time_frame>
    <description>For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline</measure>
    <time_frame>Day 1 (Baseline)</time_frame>
    <description>For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6</measure>
    <time_frame>Day 6</time_frame>
    <description>For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">180</enrollment>
  <condition>Gonorrhoea</condition>
  <arm_group>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N = 70 subjects receive single oral dose , 2000 mg of AZD0914</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 2</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>N =70 subjects receive single oral dose , 3000 mg of AZD0914</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Group 3</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>N = 40 subjects receive single intramuscular dose, 500 mg of ceftriaxone</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>AZD0914</intervention_name>
    <description>AZD0914 is an antimicrobial amorphous nonsterile powder. Group 1 receive 2000 mg; Group 2 receive 3000 mg. The drug name is also known as ETX0914.</description>
    <arm_group_label>Group 1</arm_group_label>
    <arm_group_label>Group 2</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Ceftriaxone</intervention_name>
    <description>Ceftriaxone is a broad-spectrum cephalosporin antibiotic with a very long half-life and high penetrability to meninges, eyes and inner ears. A white to yellowish orange crystalline powder. Group 3 receives 500 mg reconstituted with 1 ml Lidocaine HCL 1%, intramuscularly.</description>
    <arm_group_label>Group 3</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        1. Untreated subjects with signs and symptoms of urethral or cervical gonorrhea, or&#xD;
        confirmed urethral or cervical gonorrhea* or any type of sexual contact in the past 14 days&#xD;
        with an infected individual. *As defined by positive culture, NAAT test, or Gram-stain 2.&#xD;
        Subject is able to give voluntary written informed consent before any study related&#xD;
        procedure is performed 3. Willingness to comply with all protocol requirements 4. Male or&#xD;
        non-pregnant female 18 to 55 years of age, inclusive 5. If the subject is female, a&#xD;
        negative urine pregnancy test at Visit 1 prior to receiving study drug 6. Subject willing&#xD;
        to abstain from anal, oral, and vaginal sexual intercourse or use condoms for 7 days&#xD;
        following study drug dosing to prevent potential gonococcal reinfection 7. Male subjects&#xD;
        must be surgically sterilized or use condoms for 7 days following study drug dosing 8.&#xD;
        Female subject must be of non-childbearing potential* or if of childbearing potential, she&#xD;
        must be using a highly effective method of birth control** *Non-childbearing potential is&#xD;
        defined as being post-menopausal for at least two years, status after bilateral&#xD;
        oophorectomy or status after hysterectomy. **Female subjects must avoid becoming pregnant&#xD;
        by using one of the following acceptable methods of birth control for 30 days prior to&#xD;
        study drug dosing: --Intrauterine contraceptive device; OR --Oral contraceptives; OR&#xD;
        --Implanon®,Nexplanon®, DepoProvera®, contraceptive skin patch or NuvaRing®, OR --Tubal&#xD;
        ligation OR --Abstinence AND --for 30 days following dosing, any method above should be&#xD;
        used plus the required use of a barrier method (condom) by the male partner (even if&#xD;
        vasectomized)&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Confirmed or suspected, complicated or systemic gonorrhea such as pelvic inflammatory&#xD;
        disease, testicular pain, epididymitis, arthritis, conjunctivitis or endocarditis or&#xD;
        clinical proctitis. 2. Known concomitant infection which would require immediate additional&#xD;
        systemic antibiotics 3. Female subject currently breastfeeding 4. Use of any systemic or&#xD;
        intravaginal antibiotics with activity against N. gonorrhoeae or systemic antivirals within&#xD;
        30 days prior to study drug administration (topical and intravaginal antifugals are&#xD;
        permitted). 5. Use of systemic corticosteroid drugs or other immunosuppressive therapy&#xD;
        within 30 days prior to enrollment 6. Cytotoxic chemotherapy or radiation therapy within&#xD;
        the previous 3 months 7. Known chronic renal, hepatic (including chronic hepatitis B or&#xD;
        hepatitis C infection) or hematologic impairment, or other condition that could interfere&#xD;
        with the absorption or metabolism of study drug 8. Any concomitant condition that, in the&#xD;
        opinion of the Investigator, would preclude an evaluation of a response or make it unlikely&#xD;
        that the course of therapy and follow-up could be completed 9. Subject HIV-infected and&#xD;
        taking antiretroviral medication -- Subject not HIV-infected and taking antiretroviral for&#xD;
        pre- or post- exposure prophylaxis -- Subject newly diagnosed with HIV infection or known&#xD;
        to be HIV infected with evidence of immunosuppression, such as documented or patient&#xD;
        reported CD4 count of &lt; 200 10. Known allergy to cephalosporin or penicillin antibiotics&#xD;
        11. Receipt or planned receipt of an investigational product in a clinical trial within 30&#xD;
        days prior to or 7 days after study dose administration 12. Female subject is not willing&#xD;
        to defer treatment for bacterial vaginosis until Visit 2 if she tests positive for&#xD;
        bacterial vaginosis at Visit 1. 13. Use of drugs that act as inducer/inhibitors of CYP3A4/5&#xD;
        or the P-gp efflux transporter* within 30 days prior to study drug administration *such as&#xD;
        itraconozale, fluconazole, ketoconazole, verapamil, diltiazem, amiodarone, felodipine,&#xD;
        carbamazepine, phenytoin, or St. John's wort 14. Subjects known to be co-infected with&#xD;
        chlamydia prior to study entry 15. Subjects with medically documented cardiac arrhythmia&#xD;
        16. Known allergy to lidocaine (or local anesthetics of the amide type, e.g., articaine,&#xD;
        bupivacaine, mepivacaine, prilocaine, ropivacaine) or the antimicrobial preservative&#xD;
        methylparaben.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Jefferson County Department of Health - STD Clinic</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35233-1502</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Indiana University - Bell Flower Clinic</name>
      <address>
        <city>Indianapolis</city>
        <state>Indiana</state>
        <zip>46202-5112</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>CrescentCare Health and Wellness Center</name>
      <address>
        <city>New Orleans</city>
        <state>Louisiana</state>
        <zip>70119</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Durham County Health Department</name>
      <address>
        <city>Durham</city>
        <state>North Carolina</state>
        <zip>27701-3720</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <name>Public Health STD Clinic</name>
      <address>
        <city>Seattle</city>
        <state>Washington</state>
        <zip>98104</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>January 5, 2016</verification_date>
  <study_first_submitted>September 19, 2014</study_first_submitted>
  <study_first_submitted_qc>October 2, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">October 7, 2014</study_first_posted>
  <results_first_submitted>December 15, 2016</results_first_submitted>
  <results_first_submitted_qc>December 15, 2016</results_first_submitted_qc>
  <results_first_posted type="Estimate">February 8, 2017</results_first_posted>
  <last_update_submitted>February 16, 2017</last_update_submitted>
  <last_update_submitted_qc>February 16, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">March 22, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>antibiotic</keyword>
  <keyword>antimicrobial</keyword>
  <keyword>AZD0914</keyword>
  <keyword>Ceftriaxone</keyword>
  <keyword>drug-resistant</keyword>
  <keyword>sexually transmitted infection</keyword>
  <keyword>urogenital gonorrhoea</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gonorrhea</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Ceftriaxone</mesh_term>
    <mesh_term>Zoliflodacin</mesh_term>
  </intervention_browse>

  <clinical_results>

    <participant_flow>
      <recruitment_details>Untreated participants with signs and symptoms of urethral or cervical gonorrhea, or confirmed urethral or cervical gonorrhea as defined by positive culture, NAAT test, or Gram-stain or any type of sexual contact in the past 14 days with an infected individual were enrolled between 25NOV2014 and 02DEC2015.</recruitment_details>
      <group_list>
        <group group_id="P1">
          <title>AZD0914/ETX0914 2000mg</title>
          <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
        </group>
        <group group_id="P2">
          <title>AZD0914/ETX0914 3000mg</title>
          <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
        </group>
        <group group_id="P3">
          <title>Ceftriaxone 500mg</title>
          <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
        </group>
      </group_list>
      <period_list>
        <period>
          <title>Overall Study</title>
          <milestone_list>
            <milestone>
              <title>STARTED</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="67"/>
                <participants group_id="P3" count="41"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>Test of Cure Visit</title>
              <participants_list>
                <participants group_id="P1" count="72"/>
                <participants group_id="P2" count="67"/>
                <participants group_id="P3" count="40"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="68"/>
                <participants group_id="P2" count="66"/>
                <participants group_id="P3" count="39"/>
              </participants_list>
            </milestone>
            <milestone>
              <title>NOT COMPLETED</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="2"/>
              </participants_list>
            </milestone>
          </milestone_list>
          <drop_withdraw_reason_list>
            <drop_withdraw_reason>
              <title>Lost to Follow-up</title>
              <participants_list>
                <participants group_id="P1" count="4"/>
                <participants group_id="P2" count="1"/>
                <participants group_id="P3" count="0"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Withdrawal by Subject</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
            <drop_withdraw_reason>
              <title>Pregnancy</title>
              <participants_list>
                <participants group_id="P1" count="0"/>
                <participants group_id="P2" count="0"/>
                <participants group_id="P3" count="1"/>
              </participants_list>
            </drop_withdraw_reason>
          </drop_withdraw_reason_list>
        </period>
      </period_list>
    </participant_flow>

    <baseline>
      <population>All participants enrolled and randomized are included in the baseline analysis population.</population>
      <group_list>
        <group group_id="B1">
          <title>AZD0914/ETX0914 2000mg</title>
          <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
        </group>
        <group group_id="B2">
          <title>AZD0914/ETX0914 3000mg</title>
          <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
        </group>
        <group group_id="B3">
          <title>Ceftriaxone 500mg</title>
          <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
        </group>
        <group group_id="B4">
          <title>Total</title>
          <description>Total of all reporting groups</description>
        </group>
      </group_list>
      <analyzed_list>
        <analyzed>
          <units>Participants</units>
          <scope>Overall</scope>
          <count_list>
            <count group_id="B1" value="72"/>
            <count group_id="B2" value="67"/>
            <count group_id="B3" value="41"/>
            <count group_id="B4" value="180"/>
          </count_list>
        </analyzed>
      </analyzed_list>
      <measure_list>
        <measure>
          <title>Age</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>&lt;=18 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Between 18 and 65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="180"/>
                  </measurement_list>
                </category>
                <category>
                  <title>&gt;=65 years</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Age</title>
          <units>years</units>
          <param>Mean</param>
          <dispersion>Standard Deviation</dispersion>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="29.2" spread="8.9"/>
                    <measurement group_id="B2" value="28.3" spread="7.6"/>
                    <measurement group_id="B3" value="29.1" spread="8.2"/>
                    <measurement group_id="B4" value="28.8" spread="8.2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Sex: Female, Male</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Female</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="8"/>
                    <measurement group_id="B3" value="3"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Male</title>
                  <measurement_list>
                    <measurement group_id="B1" value="70"/>
                    <measurement group_id="B2" value="59"/>
                    <measurement group_id="B3" value="38"/>
                    <measurement group_id="B4" value="167"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Ethnicity (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="5"/>
                    <measurement group_id="B2" value="4"/>
                    <measurement group_id="B3" value="4"/>
                    <measurement group_id="B4" value="13"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Not Hispanic or Latino</title>
                  <measurement_list>
                    <measurement group_id="B1" value="67"/>
                    <measurement group_id="B2" value="63"/>
                    <measurement group_id="B3" value="37"/>
                    <measurement group_id="B4" value="167"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Race (NIH/OMB)</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <title>American Indian or Alaska Native</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Asian</title>
                  <measurement_list>
                    <measurement group_id="B1" value="1"/>
                    <measurement group_id="B2" value="2"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="3"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Native Hawaiian or Other Pacific Islander</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="0"/>
                    <measurement group_id="B3" value="1"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Black or African American</title>
                  <measurement_list>
                    <measurement group_id="B1" value="44"/>
                    <measurement group_id="B2" value="40"/>
                    <measurement group_id="B3" value="23"/>
                    <measurement group_id="B4" value="107"/>
                  </measurement_list>
                </category>
                <category>
                  <title>White</title>
                  <measurement_list>
                    <measurement group_id="B1" value="24"/>
                    <measurement group_id="B2" value="19"/>
                    <measurement group_id="B3" value="15"/>
                    <measurement group_id="B4" value="58"/>
                  </measurement_list>
                </category>
                <category>
                  <title>More than one race</title>
                  <measurement_list>
                    <measurement group_id="B1" value="2"/>
                    <measurement group_id="B2" value="5"/>
                    <measurement group_id="B3" value="2"/>
                    <measurement group_id="B4" value="9"/>
                  </measurement_list>
                </category>
                <category>
                  <title>Unknown or Not Reported</title>
                  <measurement_list>
                    <measurement group_id="B1" value="0"/>
                    <measurement group_id="B2" value="1"/>
                    <measurement group_id="B3" value="0"/>
                    <measurement group_id="B4" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Region of Enrollment</title>
          <units>participants</units>
          <param>Number</param>
          <class_list>
            <class>
              <title>United States</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="72"/>
                    <measurement group_id="B2" value="67"/>
                    <measurement group_id="B3" value="41"/>
                    <measurement group_id="B4" value="180"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
        <measure>
          <title>Positive culture result for N. gonorrhoeae</title>
          <units>Participants</units>
          <param>Count of Participants</param>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="B1" value="57"/>
                    <measurement group_id="B2" value="56"/>
                    <measurement group_id="B3" value="28"/>
                    <measurement group_id="B4" value="141"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </measure_list>
    </baseline>

    <outcome_list>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm</title>
        <description>Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.</description>
        <time_frame>Day 6</time_frame>
        <population>The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the urethral/cervical site at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm</title>
          <description>Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.</description>
          <population>The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the urethral/cervical site at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="55"/>
                    <measurement group_id="O2" value="54"/>
                    <measurement group_id="O3" value="28"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Primary</type>
        <title>Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.</title>
        <description>Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.</description>
        <time_frame>Day 1 through Day 31</time_frame>
        <population>All participants who received the study treatment were included in the analysis population. One participant enrolled in the Ceftriaxone arm was pregnant at enrollment and therefore, not treated.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.</title>
          <description>Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.</description>
          <population>All participants who received the study treatment were included in the analysis population. One participant enrolled in the Ceftriaxone arm was pregnant at enrollment and therefore, not treated.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="72"/>
                <count group_id="O2" value="67"/>
                <count group_id="O3" value="40"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Related AEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="9"/>
                    <measurement group_id="O2" value="12"/>
                    <measurement group_id="O3" value="6"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Related SAEs</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm</title>
        <description>Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.</description>
        <time_frame>Day 6</time_frame>
        <population>The analysis population was limited to participants who had a positive culture result at the rectal site for N. gonorrhoeae at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm</title>
          <description>Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.</description>
          <population>The analysis population was limited to participants who had a positive culture result at the rectal site for N. gonorrhoeae at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm</title>
        <description>Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.</description>
        <time_frame>Day 6</time_frame>
        <population>The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the pharyngeal site at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm</title>
          <description>Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.</description>
          <population>The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at the pharyngeal site at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="4"/>
                    <measurement group_id="O2" value="9"/>
                    <measurement group_id="O3" value="4"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With Clinical Cure in Each Study Arm</title>
        <description>A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator's assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator's assessment was the final adjudicator.</description>
        <time_frame>Day 6</time_frame>
        <population>The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at any anatomical site and reported signs or symptoms of gonorrhea at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With Clinical Cure in Each Study Arm</title>
          <description>A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator's assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator's assessment was the final adjudicator.</description>
          <population>The analysis population was restricted to participants who had a positive culture result for N. gonorrhoeae at any anatomical site and reported signs or symptoms of gonorrhea at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="49"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="52"/>
                    <measurement group_id="O2" value="46"/>
                    <measurement group_id="O3" value="26"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.</title>
        <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
        <time_frame>Day 1 (Baseline)</time_frame>
        <population>The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.</title>
          <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
          <population>The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="1"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.</title>
        <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
        <time_frame>Day 6</time_frame>
        <population>The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.</title>
          <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
          <population>The analysis population was restricted to participants who had a positive cervical/urethral culture result for N. gonorrhoeae at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="52"/>
                <count group_id="O3" value="28"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="48"/>
                    <measurement group_id="O2" value="42"/>
                    <measurement group_id="O3" value="25"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm</title>
        <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
        <time_frame>Baseline and Day 6</time_frame>
        <population>The analysis population was restricted to participants who had a positive rectal culture result for N. gonorrhoeae at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm</title>
          <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
          <population>The analysis population was restricted to participants who had a positive rectal culture result for N. gonorrhoeae at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="7"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="5"/>
                    <measurement group_id="O2" value="7"/>
                    <measurement group_id="O3" value="3"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm</title>
        <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
        <time_frame>Baseline and Day 6</time_frame>
        <population>The analysis population was restricted to participants who had a positive pharyngeal culture result for N. gonorrhoeae at baseline.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm</title>
          <description>Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.</description>
          <population>The analysis population was restricted to participants who had a positive pharyngeal culture result for N. gonorrhoeae at baseline.</population>
          <units>Participants</units>
          <param>Count of Participants</param>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>Baseline</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0"/>
                    <measurement group_id="O2" value="0"/>
                    <measurement group_id="O3" value="0"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Day 6</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="2"/>
                    <measurement group_id="O2" value="6"/>
                    <measurement group_id="O3" value="2"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline</title>
        <description>For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
        <time_frame>Day 1 (Baseline)</time_frame>
        <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline</title>
          <description>For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
          <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
          <units>µg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="57"/>
                <count group_id="O2" value="56"/>
                <count group_id="O3" value="27"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AZD0914/ETX0914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.125" lower_limit="0.008" upper_limit="0.250"/>
                    <measurement group_id="O2" value="0.093" lower_limit="0.008" upper_limit="0.250"/>
                    <measurement group_id="O3" value="0.060" lower_limit="0.008" upper_limit="0.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ceftriaxone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.008" lower_limit="0.001" upper_limit="0.030"/>
                    <measurement group_id="O2" value="0.008" lower_limit="0.001" upper_limit="0.060"/>
                    <measurement group_id="O3" value="0.004" lower_limit="0.001" upper_limit="0.030"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6</title>
        <description>For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
        <time_frame>Day 6</time_frame>
        <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6</title>
          <description>For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
          <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
          <units>µg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="2"/>
                <count group_id="O2" value="1"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AZD0914/ETX0914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.188" lower_limit="0.125" upper_limit="0.250"/>
                    <measurement group_id="O2" value="0.060" lower_limit="0.060" upper_limit="0.060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ceftriaxone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.012" lower_limit="0.008" upper_limit="0.015"/>
                    <measurement group_id="O2" value="0.001" lower_limit="0.001" upper_limit="0.001"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline</title>
        <description>For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
        <time_frame>Day 1 (Baseline)</time_frame>
        <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline</title>
          <description>For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
          <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
          <units>µg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="5"/>
                <count group_id="O2" value="6"/>
                <count group_id="O3" value="3"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AZD0914/ETX0914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.060" lower_limit="0.030" upper_limit="0.125"/>
                    <measurement group_id="O2" value="0.093" lower_limit="0.060" upper_limit="0.250"/>
                    <measurement group_id="O3" value="0.125" lower_limit="0.008" upper_limit="0.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ceftriaxone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.004" lower_limit="0.001" upper_limit="0.015"/>
                    <measurement group_id="O2" value="0.008" lower_limit="0.004" upper_limit="0.008"/>
                    <measurement group_id="O3" value="0.004" lower_limit="0.004" upper_limit="0.008"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Day 6</title>
        <description>For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
        <time_frame>Day 6</time_frame>
        <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint, of which there were none for this anatomical site and timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Day 6</title>
          <description>For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
          <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint, of which there were none for this anatomical site and timepoint.</population>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="0"/>
                <count group_id="O2" value="0"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AZD0914/ETX0914</title>
            </class>
            <class>
              <title>Ceftriaxone</title>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline</title>
        <description>For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
        <time_frame>Day 1 (Baseline)</time_frame>
        <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline</title>
          <description>For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
          <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
          <units>µg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="8"/>
                <count group_id="O2" value="11"/>
                <count group_id="O3" value="4"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AZD0914/ETX0914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.060" lower_limit="0.030" upper_limit="0.250"/>
                    <measurement group_id="O2" value="0.125" lower_limit="0.008" upper_limit="0.250"/>
                    <measurement group_id="O3" value="0.093" lower_limit="0.060" upper_limit="0.250"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ceftriaxone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.008" lower_limit="0.001" upper_limit="0.030"/>
                    <measurement group_id="O2" value="0.008" lower_limit="0.004" upper_limit="0.060"/>
                    <measurement group_id="O3" value="0.006" lower_limit="0.002" upper_limit="0.060"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
      <outcome>
        <type>Secondary</type>
        <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6</title>
        <description>For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
        <time_frame>Day 6</time_frame>
        <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
        <group_list>
          <group group_id="O1">
            <title>AZD0914/ETX0914 2000mg</title>
            <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O2">
            <title>AZD0914/ETX0914 3000mg</title>
            <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
          </group>
          <group group_id="O3">
            <title>Ceftriaxone 500mg</title>
            <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
          </group>
        </group_list>
        <measure>
          <title>Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6</title>
          <description>For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.</description>
          <population>The analysis population includes all participants who had isolates collected and results reported at the timepoint.</population>
          <units>µg/mL</units>
          <param>Median</param>
          <dispersion>Full Range</dispersion>
          <analyzed_list>
            <analyzed>
              <units>Participants</units>
              <scope>Measure</scope>
              <count_list>
                <count group_id="O1" value="4"/>
                <count group_id="O2" value="2"/>
                <count group_id="O3" value="0"/>
              </count_list>
            </analyzed>
          </analyzed_list>
          <class_list>
            <class>
              <title>AZD0914/ETX0914</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.125" lower_limit="0.060" upper_limit="0.250"/>
                    <measurement group_id="O2" value="0.093" lower_limit="0.060" upper_limit="0.125"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
            <class>
              <title>Ceftriaxone</title>
              <category_list>
                <category>
                  <measurement_list>
                    <measurement group_id="O1" value="0.012" lower_limit="0.004" upper_limit="0.030"/>
                    <measurement group_id="O2" value="0.012" lower_limit="0.008" upper_limit="0.015"/>
                  </measurement_list>
                </category>
              </category_list>
            </class>
          </class_list>
        </measure>
      </outcome>
    </outcome_list>

    <reported_events>
      <time_frame>All serious and non-serious adverse events were collected for 30 days after study product administration</time_frame>
      <desc>One enrolled participant was not subsequently treated and is not included in the number at risk.</desc>
      <group_list>
        <group group_id="E1">
          <title>AZD0914/ETX0914 2000mg</title>
          <description>Participants receive single oral dose of 2000 mg of AZD0914/ETX0914.</description>
        </group>
        <group group_id="E2">
          <title>AZD0914/ETX0914 3000mg</title>
          <description>Participants receive single oral dose of 3000 mg of AZD0914/ETX0914.</description>
        </group>
        <group group_id="E3">
          <title>Ceftriaxone 500mg</title>
          <description>Participants receive single intramuscular dose of 500 mg of ceftriaxone.</description>
        </group>
      </group_list>
      <serious_events>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, serious adverse events</sub_title>
                <counts group_id="E1" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E2" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Injury, poisoning and procedural complications</title>
            <event_list>
              <event>
                <sub_title>Gun shot wound</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E2" events="1" subjects_affected="1" subjects_at_risk="67"/>
                <counts group_id="E3" events="0" subjects_affected="0" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </serious_events>
      <other_events>
        <frequency_threshold>5</frequency_threshold>
        <default_vocab>MedDRA (16.1)</default_vocab>
        <default_assessment>Non-systematic Assessment</default_assessment>
        <category_list>
          <category>
            <title>Total</title>
            <event_list>
              <event>
                <sub_title>Total, other adverse events</sub_title>
                <counts group_id="E1" subjects_affected="6" subjects_at_risk="72"/>
                <counts group_id="E2" subjects_affected="12" subjects_at_risk="67"/>
                <counts group_id="E3" subjects_affected="11" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Gastrointestinal disorders</title>
            <event_list>
              <event>
                <sub_title>Diarrhoea</sub_title>
                <counts group_id="E1" events="4" subjects_affected="4" subjects_at_risk="72"/>
                <counts group_id="E2" events="2" subjects_affected="2" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>General disorders</title>
            <event_list>
              <event>
                <sub_title>Injection Site Pain</sub_title>
                <description>Only the ceftriaxone arm received the study product via injection.</description>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="0"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Infections and infestations</title>
            <event_list>
              <event>
                <sub_title>Gonorrhea</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E2" events="4" subjects_affected="4" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
              <event>
                <sub_title>Urethritis</sub_title>
                <counts group_id="E1" events="1" subjects_affected="1" subjects_at_risk="72"/>
                <counts group_id="E2" events="0" subjects_affected="0" subjects_at_risk="67"/>
                <counts group_id="E3" events="3" subjects_affected="3" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
          <category>
            <title>Nervous system disorders</title>
            <event_list>
              <event>
                <sub_title>Headache</sub_title>
                <counts group_id="E1" events="0" subjects_affected="0" subjects_at_risk="72"/>
                <counts group_id="E2" events="6" subjects_affected="6" subjects_at_risk="67"/>
                <counts group_id="E3" events="2" subjects_affected="2" subjects_at_risk="40"/>
              </event>
            </event_list>
          </category>
        </category_list>
      </other_events>
    </reported_events>

    <certain_agreements>
      <pi_employee>Principal Investigators are NOT employed by the organization sponsoring the study.</pi_employee>
      <restrictive_agreement>The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.</restrictive_agreement>
    </certain_agreements>
    <point_of_contact>
      <name_or_title>Stephanie N. Taylor, MD</name_or_title>
      <organization>Louisiana State University Health Sciences Center</organization>
      <phone>(504) 658-2622</phone>
      <email>staylo2@lsuhsc.edu</email>
    </point_of_contact>
  </clinical_results>
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT02257918
org study id: 14-0014
secondary id: HHSN272201300012I
nct id: NCT02257918
lead sponsor: 
is fda regulated drug: Yes
is fda regulated device: No
is us export: No
This is a multi-center Phase 2 randomized, open-label study in approximately 180 adult male
      and female subjects, between the ages of 18 and 55, who are in good health and meet all
      eligibility criteria. The study is designed to assess the safety and efficacy of an
      antimicrobial investigational product, AZD0914 manufactured by AstraZeneca, administered to
      adults to treat uncomplicated urogenital gonorrhea compared to treatment with ceftriaxone.
      Subjects will be randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of
      AZD0914, 3000 mg of AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The drug name is
      also known as ETX0914.
Uncomplicated gonorrhea is currently the second most common bacterial sexually transmitted
      infection (STI) worldwide and, accordingly, is a serious public health problem. This is a
      multi-center Phase 2 randomized, open-label study in approximately 180 adult male and female
      subjects, between the ages of 18 and 55, with uncomplicated cervical or urethral gonorrhea.
      The study is designed to assess the safety and efficacy of an antimicrobial investigational
      product, AZD0914 manufactured by AstraZeneca, administered to adults to treat uncomplicated
      urogenital gonorrhea compared to treatment with intramuscular ceftriaxone. Subjects will be
      randomly assigned 70:70:40 to receive a single, oral dose of 2000 mg of AZD0914, 3000 mg of
      AZD0914, or intramuscular dose of 500 mg of ceftriaxone. The study duration is 11 months and
      subject participation of 30 days. Subjects with 1) untreated urethral or cervical gonorrhea
      identified via laboratory testing at a prior visit, or 2) untreated subjects acknowledging
      anal, oral, or vaginal sexual contact in the past 14 days with someone diagnosed with
      gonorrhea, or 3) signs and symptoms of urethral or cervical gonorrhea will be offered
      enrollment in the study and consented. The primary objective assess the efficacy by
      microbiological cure rate of 2000 mg or 3000 mg AZD0914 compared to 500 mg ceftriaxone for
      the treatment of uncomplicated urogenital gonorrhea. The second primary objective assess the
      safety and tolerability of a single oral dose of 200 mg or 3000 mg AZD0914 compared to 500 mg
      ceftriaxone in adult subjects with uncomplicated urogenital gonorrhea. The drug name is also
      known as ETX0914.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
measure: Number of Participants With Microbiological Cure at Urethral or Cervical Sites in Each Study Arm
time frame: Day 6
description: Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. Male participants were swabbed at the urethral site and female participants at the cervical site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
measure: Number of Participants Reporting Adverse Events (AEs) and Serious Adverse Events (SAEs) Considered Product-related.
time frame: Day 1 through Day 31
description: Adverse events are defined as any untoward medical occurrence regardless of its causal relationship to the study treatment. Serious adverse events included any untoward medical occurrence that resulted in death; was life threatening; was a persistent/significant disability/incapacity; required inpatient hospitalization or prolongation thereof was a congenital anomaly/birth defect; or may have jeopardized the subject or required intervention to prevent one of the outcomes. Relationship to study product was determined by the investigator and defined as a reasonable possibility that the study product caused the adverse event. Reasonable possibility means that there is evidence to suggest a causal relationship between the study product and the adverse event.
measure: Number of Participants With Microbiological Cure at Rectal Sites in Each Study Arm
time frame: Day 6
description: Microbiological cure was assessed at the TOC visit. Microbiological cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All participants were swabbed at the rectal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A subject was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
measure: Number of Participants With Microbiological Cure at Pharyngeal Sites in Each Study Arm
time frame: Day 6
description: Microbiological cure was assessed at the Test of Cure visit (TOC). Microbiological Cure was derived from the Neisseria gonorrhoeae culture result and assessed by anatomical site. All subjects were swabbed at the pharyngeal site. Remel RapID NH tests were performed on pure cultures obtained from swab specimens. A participant was defined as a microbiological cure if N. gonorrhoeae was not detectable by culture at TOC.
measure: Number of Participants With Clinical Cure in Each Study Arm
time frame: Day 6
description: A clinical cure was defined as the resolution of all signs and symptoms of gonorrhea (e.g. cervical/vaginal/urethral discharge, dysuria, dyspareunia, vulvovaginal irritation, sore throat) that were present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. A clinical failure was defined by the presence of any sign or symptom of gonorrhea that was also present at enrollment with the exception of vaginal discharge due to yeast vaginitis or bacterial vaginosis. The investigator also submitted his/her determination of whether the participant met or did not meet the criteria for clinical cure (or whether it is unknown if the participant met the criteria). In the event the investigator's assessment of clinical cure did not coincide with the definitions of clinical cure/failure, the investigator's assessment was the final adjudicator.
measure: Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Baseline.
time frame: Day 1 (Baseline)
description: Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
measure: Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Urethral/Cervical Specimens in Each Study Arm at Day 6.
time frame: Day 6
description: Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at Day 6 with specimens collected at the cervical/urethral site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
measure: Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Rectal Specimens in Each Study Arm
time frame: Baseline and Day 6
description: Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the rectal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
measure: Number of Participants With no Detectable N. Gonorrhoeae Nucleic Acid in Pharyngeal Specimens in Each Study Arm
time frame: Baseline and Day 6
description: Gonorrhea and Chlamydia nucleic acid amplification tests (GC/CT NAAT) were performed at baseline and Day 6 with specimens collected at the pharyngeal site. Detectable nucleic acid was derived from GC/CT NAAT testing. If N. gonorrhoeae nucleic acid was detected, the result of the test was classified as positive. If no nucleic acid was detected, the result of the test was classified as negative. If a clear result could not be determined for any reason, the result of the test was classified as indeterminate.
measure: Median in Vitro Minimum Inhibitory Concentrations (MIC) Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Baseline
time frame: Day 1 (Baseline)
description: For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the minimum inhibitory concentration (MIC) was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
measure: Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Urethral/Cervical Sites at Day 6
time frame: Day 6
description: For all positive cultures of specimens collected from the urethra or cervix, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
measure: Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Baseline
time frame: Day 1 (Baseline)
description: For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
measure: Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Rectal Site at Day 6
time frame: Day 6
description: For all positive cultures of specimens collected from the rectum, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
measure: Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Baseline
time frame: Day 1 (Baseline)
description: For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
measure: Median in Vitro MIC Against AZD0914/ETX0914 and Ceftriaxone of Gonococcal Isolates From Culture of Isolates From the Pharyngeal Site at Day 6
time frame: Day 6
description: For all positive cultures of specimens collected from the pharynx, isolates were collected and tested for antimicrobial susceptibility profiles and the MIC was determined. MIC was defined as the lowest concentration of an antimicrobial that inhibited the visible growth of a microorganism after overnight incubation. The MIC breakpoint was a chosen concentration of an antibiotic which defines whether a bacterial isolate is susceptible or resistant to the antibiotic. If the MIC was less than or equal to the susceptibility breakpoint, the bacteria was considered susceptible to the antibiotic. If the MIC was greater than this value, the bacteria was considered intermediate or resistant to the antibiotic.
arm group label: Group 1
arm group type: Experimental
description: N = 70 subjects receive single oral dose , 2000 mg of AZD0914
arm group label: Group 2
arm group type: Experimental
description: N =70 subjects receive single oral dose , 3000 mg of AZD0914
arm group label: Group 3
arm group type: Active Comparator
description: N = 40 subjects receive single intramuscular dose, 500 mg of ceftriaxone
intervention type: Drug
intervention name: AZD0914
description: AZD0914 is an antimicrobial amorphous nonsterile powder. Group 1 receive 2000 mg; Group 2 receive 3000 mg. The drug name is also known as ETX0914.
arm group label: Group 1
arm group label: Group 2
intervention type: Drug
intervention name: Ceftriaxone
description: Ceftriaxone is a broad-spectrum cephalosporin antibiotic with a very long half-life and high penetrability to meninges, eyes and inner ears. A white to yellowish orange crystalline powder. Group 3 receives 500 mg reconstituted with 1 ml Lidocaine HCL 1%, intramuscularly.
arm group label: Group 3
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
facility: 
facility: 
facility: 
facility: 
facility: 
country: United States
responsible party type: Sponsor
mesh term: Gonorrhea
mesh term: Ceftriaxone
mesh term: Zoliflodacin
participant flow: 
baseline: 
outcome list: 
reported events: 
certain agreements: 
point of contact: 