E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
asymptomatic pharyngeal Neisseria gonorrhoeae (NG) |
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E.1.1.1 | Medical condition in easily understood language |
asymptomatic gonorrhoeae in the mouth/throat |
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E.1.1.2 | Therapeutic area | Diseases [C] - Bacterial Infections and Mycoses [C01] |
MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 21.1 |
E.1.2 | Level | LLT |
E.1.2 | Classification code | 10051970 |
E.1.2 | Term | Neisseria gonorrhoeae infection |
E.1.2 | System Organ Class | 100000004862 |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
Assess if pharyngeal NG infection is eradicated after 6 days of Chlorhexidine mouthwash and gargling |
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E.2.2 | Secondary objectives of the trial |
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 |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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 |
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E.4 | Principal 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 |
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E.5 End points |
E.5.1 | 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). |
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E.5.1.1 | Timepoint(s) of evaluation of this end point |
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E.5.2 | Secondary end point(s) |
1) 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). 2) Assess if there is a decline in NG bacterial load over time under treatment with MWG with chlorhexidine. 3) Assess the time to culture negativity under treatment with MWG with chlorhexidine 4) Assess if MWG with chlorhexidine 0.2% x 60 seconds twice a day for six days is able to eradicate pharyngeal NG based on NAAT conversion by day 14 (range 13-15 days). 5) Assess if MWG with chlorhexidine 0.2% x 60 seconds twice a day for six days is able to eradicate pharyngeal NG based on NAAT conversion by day 14 (range 13-15 days). 6) 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 negativity by day 14 (range 13-15 days). 7) 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 negativity by day 14 (range 13-15 days). 8) Assess if MWG with chlorhexidine 0.2% x 60 seconds twice a day for six days results in changes in pharyngeal microbiome and resistome before versus 14 days (range 13-15 days) after the start of chlorhexidine MWG therapy. 9) Assess the safety of the use of MWG with chlorhexidine 0.2% twice a day for 6 days
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E.5.2.1 | Timepoint(s) of evaluation of this end point |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | No |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | Yes |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | No |
E.6.13 | Others | No |
E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | No |
E.8.1.1 | Randomised | No |
E.8.1.2 | Open | No |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | No |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | Yes |
E.8.1.7.1 | Other trial design description |
Single center, single arm, open-label pilot study. |
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E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | No |
E.8.2.4 | Number of treatment arms in the trial | 1 |
E.8.3 |
The trial involves single site in the Member State concerned
| Yes |
E.8.4 | The trial involves multiple sites in the Member State concerned | No |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | No |
E.8.7 | Trial has a data monitoring committee | No |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 2 |
E.8.9.1 | In the Member State concerned months | |
E.8.9.1 | In the Member State concerned days | |