EUCTR2019-003604-12-BE
Active, not recruiting
Phase 1
Evaluation of a chlorhexidine mouthwash for the eradication of asymptomatic pharyngeal Neisseria gonorrhoeae infection - MoNg study
Institute of Tropical Medicine0 sites100 target enrollmentDecember 5, 2019
Conditionsasymptomatic pharyngeal Neisseria gonorrhoeae (NG)MedDRA version: 21.1Level: LLTClassification code 10051970Term: Neisseria gonorrhoeae infectionSystem Organ Class: 100000004862Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]
DrugsCorsodyl
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- asymptomatic pharyngeal Neisseria gonorrhoeae (NG)
- Sponsor
- Institute of Tropical Medicine
- Enrollment
- 100
- Status
- Active, not recruiting
- Last Updated
- 3 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •1\. Able and willing to provide written informed consent
- •2\. Male sex at birth
- •3\. At least 18 years old
- •4\. Having had sex with another man within the previous 12 months
- •5\. Confirmed diagnosis of asymptomatic pharyngeal NG infection as defined by no symptoms of pharyngitis and no signs of disseminated gonococcal disease plus test positive for NG on NAAT or culture within the previous 14 days.
- •6\. Willing to abstain from any sexual intercourse until the result of the final test\-of\-cure is reported to be negative
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1\.2 Adults (18\-64 years) yes
- •F.1\.2\.1 Number of subjects for this age range 90
Exclusion Criteria
- •1\. Known contra\-indication or allergy to chlorhexidine
- •2\. Proven gonococcal infection elsewhere, signs of disseminated gonococcal disease or proven or suspected coinfection with Chlamydia trachomatis (CT) or syphilis at the time of the screening visit.
- •3\. Currently using a mouthwash and unwilling to stop using it for the duration of the study or being included in another research project using mouthwashes
- •4\. Currently taking any antibiotics or having taken any antibiotics in the previous 14 days
Outcomes
Primary Outcomes
Not specified
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