xml: <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/NCT05971550</url>
    </required_header>
    <id_info>
      <org_study_id>APHP210080</org_study_id>
      <nct_id>NCT05971550</nct_id>
    </id_info>
    <brief_title>Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study</brief_title>
    <acronym>PORTAPHAR</acronym>
    <official_title>Clearance of Asymptomatic Pharyngeal Carriage of Neisseria Gonorrhoeae With or Without Ceftriaxone Treatment: Randomized Non-inferiority Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Assistance Publique - Hôpitaux de Paris</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Assistance Publique - Hôpitaux de Paris</source>
    <oversight_info>
      <has_dmc>Yes</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Since the use of antibiotics, Neisseria Gonorrhoeae (NG) has acquired progressive resistance&#xD;
        to penicillins, sulfonamides, tetracyclines and quinolones. The oropharynx is recognized as&#xD;
        an important site for DNA exchange between NG and other commensal Neisseria, allowing NG to&#xD;
        acquire new antimicrobial resistance. Despite the worrying data on the emergence of resistant&#xD;
        NG, the recommendations remain to systematically treat these infections with ceftriaxone,&#xD;
        including asymptomatic pharyngeal localizations. The objective of our study is to evaluate a&#xD;
        ceftriaxone sparing strategy in order to limit the emergence of antibiotic resistance.&#xD;
  &#xD;
        The primary objective of the study is to evaluate the clearance of Neisseria gonorrhoeae, 3&#xD;
        months after the diagnosis of asymptomatic pharyngeal carriage documented on nucleic acid&#xD;
        amplification test (NAAT).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Non-inferiority, multicenter, prospective, randomized open-label study, in two parallel arms,&#xD;
        comparing the pharyngeal clearance of Neisseria gonorrhoeae (NG) at 3 months with or without&#xD;
        treatment with ceftriaxone.&#xD;
  &#xD;
        Experimental group: Absence of antibiotic treatment for at most 3 months after screening for&#xD;
        asymptomatic NG pharyngeal infection (treatment if onset of symptoms related to Sexually&#xD;
        Transmitted Infection or positive Polymerase chain reaction (PCR) at 3 months)&#xD;
  &#xD;
        Control group: Ceftriaxone 1000 mg by parenteral intramuscular route, in a single dose,&#xD;
        according to the national recommendations in force, to be repeated if pharyngeal Polymerase&#xD;
        chain reaction (PCR) again positive for NG during follow-up.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</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>Other</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)</measure>
      <time_frame>3 months after inclusion</time_frame>
    </primary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) and a negative pharyngeal culture for Neisseria gonorrhoeae (NG)</measure>
      <time_frame>at 1 month after inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with negative pharyngeal NG cultures</measure>
      <time_frame>at 3 months after inclusion</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)</measure>
      <time_frame>at 1 month after inclusion</time_frame>
      <description>Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae</measure>
      <time_frame>at 1 month after inclusion</time_frame>
      <description>Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)</measure>
      <time_frame>at 3 months after inclusion</time_frame>
      <description>Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample and extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae</measure>
      <time_frame>at 3 months after inclusion</time_frame>
      <description>Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with spontaneous pharyngeal clearance of NG</measure>
      <time_frame>at 1 month after inclusion</time_frame>
      <description>Analysis of factors associated with spontaneous pharyngeal clearance of NG :&#xD;
  Socio-demographic and behavioural characteristics&#xD;
  Amount of NG in the pharynx assessed by exploratory semi-quantitative PCR&#xD;
  Bactericidal activity of anti-gonococcal antibodies and the production of specific anti-gonococcal antibodies in pharyngeal secretions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with spontaneous pharyngeal clearance of NG</measure>
      <time_frame>at 3 months after inclusion</time_frame>
      <description>Analysis of the factors associated with spontaneous pharyngeal clearance of NG :&#xD;
  Socio-demographic and behavioural characteristics&#xD;
  Amount of NG in the pharynx assessed by exploratory semi-quantitative PCR&#xD;
  Bactericidal activity of anti-gonococcal antibodies and the production of specific anti-gonococcal antibodies in pharyngeal secretions</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of partners with NAAT positive for NG</measure>
      <time_frame>At inclusion of the partner</time_frame>
      <description>Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of partners with NG cultures positive</measure>
      <time_frame>At inclusion of the partner</time_frame>
      <description>Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of partners with NAAT positive for NG</measure>
      <time_frame>at 1 month after inclusion of the partner</time_frame>
      <description>Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of partners with NG cultures positive</measure>
      <time_frame>at 1 month after inclusion of the partner</time_frame>
      <description>Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of partners with NAAT positive for NG</measure>
      <time_frame>at 3 months after inclusion of the partner</time_frame>
      <description>Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of partners with NG cultures positive</measure>
      <time_frame>at 3 months after inclusion of the partner</time_frame>
      <description>Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of identical genome between partner and patient</measure>
      <time_frame>Up to 3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of patients with Resistant NG strains</measure>
      <time_frame>Up to 3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of partners with Resistant NG strains</measure>
      <time_frame>Up to 3 months</time_frame>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Proportion of adverse events</measure>
      <time_frame>Up to 3 months</time_frame>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">254</enrollment>
    <condition>Neisseria Gonorrhoeae Infection</condition>
    <condition>Asymptomatic Pharyngeal Carriage</condition>
    <arm_group>
      <arm_group_label>Patients : Absence of antibiotic treatment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Patients : Ceftriaxone</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Absence of antibiotic treatment</intervention_name>
      <description>Absence of antibiotic treatment for at most 3 months after screening for asymptomatic NG pharyngeal infection (treatment if onset of symptoms related to STI or positive PCR at 3 months)</description>
      <arm_group_label>Patients : Absence of antibiotic treatment</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Drug</intervention_type>
      <intervention_name>Ceftriaxone</intervention_name>
      <description>Ceftriaxone 1000 mg by parenteral intramuscular route, in a single dose, according to the national recommendations in force, to be repeated if pharyngeal PCR again positive for NG during follow-up</description>
      <arm_group_label>Patients : Ceftriaxone</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Patients (n=154):&#xD;
  &#xD;
          Patient inclusion criteria :&#xD;
  &#xD;
            -  Adult patient (age ≥ 18 years old)&#xD;
  &#xD;
            -  Patient consulting for a pharyngeal Neisseria gonorrhoeae Sexually Transmitted&#xD;
               Infection (STI) and meeting the following criteria :&#xD;
  &#xD;
                 -  Positive sample for NAAT by PCR in the pharynx for Neisseria gonorrhoeae dating&#xD;
                    back a maximum of 7 days (the date of the sample and those of inclusion will be&#xD;
                    compared) and&#xD;
  &#xD;
                 -  asymptomatic patient&#xD;
  &#xD;
            -  Absence of symptoms of other bacterial STIs or other asymptomatic bacterial STIs&#xD;
               confirmed on the systematic screening assessment carried out within 7 days before&#xD;
               inclusion&#xD;
  &#xD;
            -  Patient's agreement to use protection or abstinence from all oral sex for 3 months&#xD;
               follow-up (experimental group) or for 7 days (control group)&#xD;
  &#xD;
            -  For men whose female partner(s) are of childbearing age and for women of childbearing&#xD;
               age: use of effective contraception (failure rate less than 1% per year) throughout&#xD;
               research&#xD;
  &#xD;
            -  Patient benefiting from a social health security scheme&#xD;
  &#xD;
            -  Patient having signed a free and informed consent&#xD;
  &#xD;
          Patients non-inclusion criteria :&#xD;
  &#xD;
            -  Minor patient&#xD;
  &#xD;
            -  Symptomatic patient in the pharynx&#xD;
  &#xD;
            -  Presence of symptoms of another bacterial STI or of an asymptomatic bacterial STI&#xD;
               confirmed on the screening report carried out within 7 days before inclusion&#xD;
  &#xD;
            -  Antibiotic treatment that may be active on Neisseria gonorrhoeae (C3G,&#xD;
               Fluoroquinolones, Macrolides, Cyclins, Aminosides, Penicillins) within 14 days before&#xD;
               inclusion&#xD;
  &#xD;
            -  Hypersensitivity to ceftriaxone, other cephalosporins or to any of the excipients&#xD;
  &#xD;
            -  History of severe hypersensitivity (e.g. anaphylactic reaction) to another class of&#xD;
               antibacterial agents of the beta-lactam family (penicillins, monobactams and&#xD;
               carbapenems).&#xD;
  &#xD;
            -  Contraindication to ceftriaxone&#xD;
  &#xD;
            -  Contraindication to intramuscular injections&#xD;
  &#xD;
            -  Person under legal protection, under guardianship or curatorship, person deprived of&#xD;
               liberty, under safeguard of justice, subject to psychiatric care, under duress,&#xD;
               admitted to a health or social establishment for purposes other than those of research&#xD;
  &#xD;
            -  Pregnant or breastfeeding woman&#xD;
  &#xD;
            -  Lack of social health insurance&#xD;
  &#xD;
            -  Patient included in another interventional study&#xD;
  &#xD;
          Partners (n=100) :&#xD;
  &#xD;
          Partner Inclusion Criteria :&#xD;
  &#xD;
            -  Sexual contact of the index case (genito-anal or genito-vaginal, oro-genital or&#xD;
               oro-anal or oro-oral relations) in the month preceding the inclusion of the index case&#xD;
  &#xD;
            -  Adult patient (age ≥ 18 years old)&#xD;
  &#xD;
            -  Patient benefiting from a social health security scheme&#xD;
  &#xD;
            -  Patient having signed a free and informed consent&#xD;
  &#xD;
          Partner non-inclusion Criteria:&#xD;
  &#xD;
            -  Minor patient&#xD;
  &#xD;
            -  Person under legal protection, under guardianship or curatorship, person deprived of&#xD;
               liberty, under safeguard of justice, subject to psychiatric care, under duress,&#xD;
               admitted to a health or social establishment for purposes other than those of research&#xD;
  &#xD;
            -  Patient included in another interventional study&#xD;
  &#xD;
            -  Pregnant or breastfeeding woman&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_contact>
      <last_name>Claire Pintado, Dr</last_name>
      <phone>+33142494973</phone>
      <email>claire.pintado@aphp.fr</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Jérôme Lambert, Dr</last_name>
      <phone>+33142499742</phone>
      <email>jerome.lambert@u-paris.fr</email>
    </overall_contact_backup>
    <verification_date>February 2023</verification_date>
    <study_first_submitted>April 14, 2023</study_first_submitted>
    <study_first_submitted_qc>July 24, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 2, 2023</study_first_posted>
    <last_update_submitted>July 24, 2023</last_update_submitted>
    <last_update_submitted_qc>July 24, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 2, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <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>Anti-Bacterial Agents</mesh_term>
      <mesh_term>Ceftriaxone</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05971550
  org study id: APHP210080
  nct id: NCT05971550
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Since the use of antibiotics, Neisseria Gonorrhoeae (NG) has acquired progressive resistance
        to penicillins, sulfonamides, tetracyclines and quinolones. The oropharynx is recognized as
        an important site for DNA exchange between NG and other commensal Neisseria, allowing NG to
        acquire new antimicrobial resistance. Despite the worrying data on the emergence of resistant
        NG, the recommendations remain to systematically treat these infections with ceftriaxone,
        including asymptomatic pharyngeal localizations. The objective of our study is to evaluate a
        ceftriaxone sparing strategy in order to limit the emergence of antibiotic resistance.
  
        The primary objective of the study is to evaluate the clearance of Neisseria gonorrhoeae, 3
        months after the diagnosis of asymptomatic pharyngeal carriage documented on nucleic acid
        amplification test (NAAT).
  Non-inferiority, multicenter, prospective, randomized open-label study, in two parallel arms,
        comparing the pharyngeal clearance of Neisseria gonorrhoeae (NG) at 3 months with or without
        treatment with ceftriaxone.
  
        Experimental group: Absence of antibiotic treatment for at most 3 months after screening for
        asymptomatic NG pharyngeal infection (treatment if onset of symptoms related to Sexually
        Transmitted Infection or positive Polymerase chain reaction (PCR) at 3 months)
  
        Control group: Ceftriaxone 1000 mg by parenteral intramuscular route, in a single dose,
        according to the national recommendations in force, to be repeated if pharyngeal Polymerase
        chain reaction (PCR) again positive for NG during follow-up.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Other
  masking: None (Open Label)
  measure: Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) for Neisseria gonorrhoeae (NG)
  time frame: 3 months after inclusion
  measure: Proportion of patients with a negative pharyngeal nucleic acid amplification test (NAAT) and a negative pharyngeal culture for Neisseria gonorrhoeae (NG)
  time frame: at 1 month after inclusion
  measure: Proportion of patients with negative pharyngeal NG cultures
  time frame: at 3 months after inclusion
  measure: Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)
  time frame: at 1 month after inclusion
  description: Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample
  measure: Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae
  time frame: at 1 month after inclusion
  description: Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
  measure: Proportion of patients carrying methicillin-resistant Staphylococcus aureus (MRSA)
  time frame: at 3 months after inclusion
  description: Impact of ceftriaxone on the carriage of methicillin-resistant Staphylococcus aureus (MRSA) on the pharyngeal sample and extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
  measure: Proportion of patients carrying extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae
  time frame: at 3 months after inclusion
  description: Impact of ceftriaxone on the carriage of extended-spectrum beta-lactamase (ESBL)-producing Enterobacteriaceae on the anal sample
  measure: Proportion of patients with spontaneous pharyngeal clearance of NG
  time frame: at 1 month after inclusion
  description: Analysis of factors associated with spontaneous pharyngeal clearance of NG :
  Socio-demographic and behavioural characteristics
  Amount of NG in the pharynx assessed by exploratory semi-quantitative PCR
  Bactericidal activity of anti-gonococcal antibodies and the production of specific anti-gonococcal antibodies in pharyngeal secretions
  measure: Proportion of patients with spontaneous pharyngeal clearance of NG
  time frame: at 3 months after inclusion
  description: Analysis of the factors associated with spontaneous pharyngeal clearance of NG :
  Socio-demographic and behavioural characteristics
  Amount of NG in the pharynx assessed by exploratory semi-quantitative PCR
  Bactericidal activity of anti-gonococcal antibodies and the production of specific anti-gonococcal antibodies in pharyngeal secretions
  measure: Proportion of partners with NAAT positive for NG
  time frame: At inclusion of the partner
  description: Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
  measure: Proportion of partners with NG cultures positive
  time frame: At inclusion of the partner
  description: Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
  measure: Proportion of partners with NAAT positive for NG
  time frame: at 1 month after inclusion of the partner
  description: Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
  measure: Proportion of partners with NG cultures positive
  time frame: at 1 month after inclusion of the partner
  description: Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
  measure: Proportion of partners with NAAT positive for NG
  time frame: at 3 months after inclusion of the partner
  description: Proportion of partners with NAAT positive for NG on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
  measure: Proportion of partners with NG cultures positive
  time frame: at 3 months after inclusion of the partner
  description: Proportion of partners with NG cultures positive on at least one of the three sites of infection (pharyngeal, anal, first-void urine or vaginal self-sampling)
  measure: Proportion of identical genome between partner and patient
  time frame: Up to 3 months
  measure: Proportion of patients with Resistant NG strains
  time frame: Up to 3 months
  measure: Proportion of partners with Resistant NG strains
  time frame: Up to 3 months
  measure: Proportion of adverse events
  time frame: Up to 3 months
  arm group label: Patients : Absence of antibiotic treatment
  arm group type: Experimental
  arm group label: Patients : Ceftriaxone
  arm group type: Active Comparator
  intervention type: Other
  intervention name: Absence of antibiotic treatment
  description: Absence of antibiotic treatment for at most 3 months after screening for asymptomatic NG pharyngeal infection (treatment if onset of symptoms related to STI or positive PCR at 3 months)
  arm group label: Patients : Absence of antibiotic treatment
  intervention type: Drug
  intervention name: Ceftriaxone
  description: Ceftriaxone 1000 mg by parenteral intramuscular route, in a single dose, according to the national recommendations in force, to be repeated if pharyngeal PCR again positive for NG during follow-up
  arm group label: Patients : Ceftriaxone
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Claire Pintado, Dr
  phone: +33142494973
  email: claire.pintado@aphp.fr
  last name: Jérôme Lambert, Dr
  phone: +33142499742
  email: jerome.lambert@u-paris.fr
  responsible party type: Sponsor
  mesh term: Gonorrhea
  mesh term: Anti-Bacterial Agents
  mesh term: Ceftriaxone
  sharing ipd: Undecided