Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:03 PM
Ignite Modification Date:
2025-12-24 @ 5:03 PM
NCT ID:
NCT05971550
Eligibility Criteria:
Patients (n=154):
Patient inclusion criteria :
* Adult patient (age ≥ 18 years old)
* Patient consulting for a pharyngeal Neisseria gonorrhoeae Sexually Transmitted Infection (STI) and meeting the following criteria :
* Positive sample for NAAT by PCR in the pharynx for Neisseria gonorrhoeae dating back a maximum of 7 days (the date of the sample and those of inclusion will be compared) and
* asymptomatic patient
* Absence of symptoms of other bacterial STIs or other asymptomatic bacterial STIs confirmed on the systematic screening assessment carried out within 7 days before inclusion
* Patient's agreement to use protection or abstinence from all oral sex for 3 months follow-up (experimental group) or for 7 days (control group)
* For men whose female partner(s) are of childbearing age and for women of childbearing age: use of effective contraception (failure rate less than 1% per year) throughout research
* Patient benefiting from a social health security scheme
* Patient having signed a free and informed consent
Patients non-inclusion criteria :
* Minor patient
* Symptomatic patient in the pharynx
* Presence of symptoms of another bacterial STI or of an asymptomatic bacterial STI confirmed on the screening report carried out within 7 days before inclusion
* Antibiotic treatment that may be active on Neisseria gonorrhoeae (C3G, Fluoroquinolones, Macrolides, Cyclins, Aminosides, Penicillins) within 14 days before inclusion
* Hypersensitivity to ceftriaxone, other cephalosporins or to any of the excipients
* History of severe hypersensitivity (e.g. anaphylactic reaction) to another class of antibacterial agents of the beta-lactam family (penicillins, monobactams and carbapenems).
* Contraindication to ceftriaxone
* Contraindication to intramuscular injections
* Person under legal protection, under guardianship or curatorship, person deprived of liberty, under safeguard of justice, subject to psychiatric care, under duress, admitted to a health or social establishment for purposes other than those of research
* Pregnant or breastfeeding woman
* Lack of social health insurance
* Patient included in another interventional study
Partners (n=100) :
Partner Inclusion Criteria :
* Sexual contact of the index case (genito-anal or genito-vaginal, oro-genital or oro-anal or oro-oral relations) in the month preceding the inclusion of the index case
* Adult patient (age ≥ 18 years old)
* Patient benefiting from a social health security scheme
* Patient having signed a free and informed consent
Partner non-inclusion Criteria:
* Minor patient
* Person under legal protection, under guardianship or curatorship, person deprived of liberty, under safeguard of justice, subject to psychiatric care, under duress, admitted to a health or social establishment for purposes other than those of research
* Patient included in another interventional study
* Pregnant or breastfeeding woman
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05971550
Study Brief:
Protocol Section:
NCT05971550