<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/NCT02210325</url>
  </required_header>
  <id_info>
    <org_study_id>CE01-302</org_study_id>
    <secondary_id>15-0091, HHSN272201300013</secondary_id>
    <nct_id>NCT02210325</nct_id>
  </id_info>
  <brief_title>Efficacy and Safety Study of Oral Solithromycin Compared to Intramuscular Ceftriaxone Plus Oral Azithromycin in the Treatment of Patients With Gonorrhea</brief_title>
  <acronym>SOLITAIRE-U</acronym>
  <official_title>An Open-Label, Randomized, Multi-Center Study to Evaluate the Efficacy and Safety of a Single Dose of Oral Solithromycin Compared to Single-Dose Intramuscular Ceftriaxone Plus Single-Dose Oral Azithromycin in the Treatment of Male and Female Patients With Uncomplicated Urogenital Gonorrhea With or Without Concomitant Chlamydia</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Melinta Therapeutics, Inc.</agency>
      <agency_class>Industry</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>National Institute of Allergy and Infectious Diseases (NIAID)</agency>
      <agency_class>NIH</agency_class>
    </collaborator>
  </sponsors>
  <source>Melinta Therapeutics, Inc.</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will compare a single dose of oral solithromycin to the standard of care&#xD;
      (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with&#xD;
      urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin&#xD;
      resulted in 100% microbiological eradication in male and female patients with uncomplicated&#xD;
      urogenital gonorrhea.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 2014</start_date>
  <completion_date type="Actual">February 22, 2017</completion_date>
  <primary_completion_date type="Actual">February 22, 2017</primary_completion_date>
  <phase>Phase 3</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>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population.</measure>
    <time_frame>7 days after treatment</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>To assess the safety and tolerability of a single oral dose of solithromycin compared to single-dose IM ceftriaxone plus single-dose oral azithromycin in patients with gonorrhea</measure>
    <time_frame>7 days</time_frame>
    <description>Adverse event frequency and severity will be compared between patients who received solithromycin and those who received ceftriaxone plus azithromycin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To compare bacterial eradication rates of N. gonorrhoeae from rectal or pharyngeal cultures following a single dose of oral solithromycin compared to single-dose IM ceftriaxone plus oral azithromycin.</measure>
    <time_frame>7 days</time_frame>
  </secondary_outcome>
  <secondary_outcome>
    <measure>To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens.</measure>
    <time_frame>21 days after treatment</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">264</enrollment>
  <condition>Uncomplicated Urogenital Gonorrhea</condition>
  <arm_group>
    <arm_group_label>Ceftriaxone plus Azithromycin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Solithromycin</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>A single oral dose of 1000 mg solithromycin</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>solithromycin</intervention_name>
    <arm_group_label>Solithromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>ceftriaxone</intervention_name>
    <arm_group_label>Ceftriaxone plus Azithromycin</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>azithromycin</intervention_name>
    <arm_group_label>Ceftriaxone plus Azithromycin</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  At least 1 of the following:&#xD;
&#xD;
               1. Untreated male with urethral gonorrhea as determined by a screening laboratory&#xD;
                  test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study&#xD;
                  drug administration.&#xD;
&#xD;
               2. Untreated female with cervical gonorrhea as determined by a screening laboratory&#xD;
                  test (either NAAT or culture) for N. gonorrhoeae within 2 weeks prior to study&#xD;
                  drug administration.&#xD;
&#xD;
               3. Urethral (male) or cervical (female) Gram stain demonstrating Gram-negative&#xD;
                  intracellular diplococci and leukocytes.&#xD;
&#xD;
          -  The patient must be willing to abstain from anal, oral, and vaginal sexual intercourse&#xD;
             or use condoms for all of these until study completion.&#xD;
&#xD;
          -  Females of childbearing potential (including females less than 2 years&#xD;
             post-menopausal) must have a negative pregnancy test at enrollment.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Confirmed or suspected complicated or systemic gonococcal infections such as pelvic&#xD;
             inflammatory disease, epididymitis, arthritis, endocarditis, or disseminated&#xD;
             gonococcal infection.&#xD;
&#xD;
          -  Individuals who have already received antibiotic treatment for their gonorrhea.&#xD;
&#xD;
          -  Use of systemic or intravaginal antibiotics within 7 days prior to study drug&#xD;
             administration.&#xD;
&#xD;
          -  Women who are pregnant or nursing.&#xD;
&#xD;
          -  Men with suspected or confirmed rectal gonorrhea and symptoms of proctitis.&#xD;
&#xD;
          -  History of significant intolerance or allergy to macrolide or cephalosporin&#xD;
             antibiotics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Marcus Chen, MD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Melbourne Sexual Health Centre</affiliation>
  </overall_official>
  <location>
    <facility>
      <address>
        <city>Baltimore</city>
        <state>Maryland</state>
        <zip>21205</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Cleveland</city>
        <state>Ohio</state>
        <zip>44109</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Toledo</city>
        <state>Ohio</state>
        <zip>43614</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Sydney</city>
        <state>New South Wales</state>
        <zip>2000</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location>
    <facility>
      <address>
        <city>Melbourne</city>
        <state>Victoria</state>
        <zip>3053</zip>
        <country>Australia</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Australia</country>
    <country>United States</country>
  </location_countries>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 1, 2014</study_first_submitted>
  <study_first_submitted_qc>August 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 6, 2014</study_first_posted>
  <last_update_submitted>September 8, 2017</last_update_submitted>
  <last_update_submitted_qc>September 8, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>gonorrhea</keyword>
  <keyword>chlamydia</keyword>
  <keyword>solithromycin</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>Azithromycin</mesh_term>
    <mesh_term>Ceftriaxone</mesh_term>
    <mesh_term>Solithromycin</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</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/NCT02210325
org study id: CE01-302
secondary id: 15-0091, HHSN272201300013
nct id: NCT02210325
lead sponsor: 
collaborator: 
has dmc: No
This study will compare a single dose of oral solithromycin to the standard of care
      (intramuscular ceftriaxone plus oral azithromycin) in the treatment of patients with
      urogenital gonorrhea. A completed open-label Phase 2 study with single doses of solithromycin
      resulted in 100% microbiological eradication in male and female patients with uncomplicated
      urogenital gonorrhea.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: To assess the eradication rate of Neisseria gonorrhoeae by culture following a single dose of oral solithromycin compared to single-dose intramuscular ceftriaxone plus oral azithromycin in the Microbiological Intent to Treat population.
time frame: 7 days after treatment
measure: To assess the safety and tolerability of a single oral dose of solithromycin compared to single-dose IM ceftriaxone plus single-dose oral azithromycin in patients with gonorrhea
time frame: 7 days
description: Adverse event frequency and severity will be compared between patients who received solithromycin and those who received ceftriaxone plus azithromycin
measure: To compare bacterial eradication rates of N. gonorrhoeae from rectal or pharyngeal cultures following a single dose of oral solithromycin compared to single-dose IM ceftriaxone plus oral azithromycin.
time frame: 7 days
measure: To assess clearance or persistence of N. gonorrhoeae and Chlamydia trachomatis nucleic acid from male and female genital, pharyngeal and rectal specimens.
time frame: 21 days after treatment
arm group label: Ceftriaxone plus Azithromycin
arm group type: Active Comparator
description: A single intramuscular dose of 500 mg ceftriaxone plus a single oral dose of 1000 mg azithromycin
arm group label: Solithromycin
arm group type: Experimental
description: A single oral dose of 1000 mg solithromycin
intervention type: Drug
intervention name: solithromycin
arm group label: Solithromycin
intervention type: Drug
intervention name: ceftriaxone
arm group label: Ceftriaxone plus Azithromycin
intervention type: Drug
intervention name: azithromycin
arm group label: Ceftriaxone plus Azithromycin
criteria: 
gender: All
minimum age: 15 Years
maximum age: N/A
healthy volunteers: No
last name: Marcus Chen, MD, PhD
role: Principal Investigator
affiliation: Melbourne Sexual Health Centre
facility: 
facility: 
facility: 
facility: 
facility: 
country: Australia
country: United States
responsible party type: Sponsor
mesh term: Gonorrhea
mesh term: Azithromycin
mesh term: Ceftriaxone
mesh term: Solithromycin
sharing ipd: No