Evaluation of a chlorhexidine mouthwash for the eradication of asymptomatic pharyngeal Neisseria gonorrhoeae infection MoNg study”
- Conditions
- asymptomatic 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]
- Registration Number
- EUCTR2019-003604-12-BE
- Lead Sponsor
- Institute of Tropical Medicine
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Male
- Target Recruitment
- 100
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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 10
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: Assess if pharyngeal NG infection is eradicated after 6 days of Chlorhexidine mouthwash and gargling;Secondary Objective: proportion of participants with a conversion from a positive to a negative pharyngeal NG culture by day 7 divided by the amount of participants that had a negative or positive result on day 7 and the participants that developed symptoms of pharyngeal NG and started antibiotics;Primary end point(s): Assess if MWG with chlorhexidine 0.2% x 60 seconds twice a day for six days is able to eradicate pharyngeal NG based on culture conversion by day 7 (range 6-8 days).;Timepoint(s) of evaluation of this end point: day 7
- Secondary Outcome Measures
Name Time Method