Evaluation of a chlorhexidine mouthwash for the eradication of asymptomatic pharyngeal Neisseria gonorrhoeae infection “MoNg study”

Evaluation of a chlorhexidine mouthwash for the eradication of asymptomatic pharyngeal Neisseria gonorrhoeae infection - MoNg study

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2019-003604-12-BE

Enrollment

100

Registered

2019-12-05

Start date

2020-01-15

Completion date

Unknown

Last updated

2022-08-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

asymptomatic pharyngeal Neisseria gonorrhoeae (NG) MedDRA version: 21.1 Level: LLT Classification code 10051970 Term: Neisseria gonorrhoeae infection System Organ Class: 100000004862

Interventions

Trade Name: Corsodyl Pharmaceutical Form: Mouthwash INN or Proposed INN: Chlorhexidine Digluconate CAS Number: 18472-51-0 Other descriptive name: CHLORHEXIDINE DIGLUCONATE SOLUTION Concentration unit:

Eligibility

Sex/Gender

Male

Inclusion 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 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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	—

Measure

Time frame

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

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Secondary

Measure	Time frame
Timepoint(s) of evaluation of this end point: day 7 and day 14 ;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	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: day 7 and day 14 ;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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Countries

Belgium

Contacts

Public ContactYven Van Herrewege

ITM Clinical Trial Unit

yvanherrewege@itg.be003233455557

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026