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A randomised trial of alcohol-containing mouthwash or saline for pharyngeal gonorrhoea among men who have sex with men

Will the use of alcohol-containing mouthwash reduce pharyngeal gonorrhoea among men who have sex with men compared to who use saline?

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12615000716561
Acronym
GONE: Gonorrhoea Eradication
Enrollment
197
Registered
2015-07-10
Start date
2015-05-22
Completion date
2016-02-02
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

Men who have sex with men tested positive for pharyngeal gonorrhoea at Melbourne Sexual Health Centre (MSHC) who volunteer will be randomised to receive an alcohol-containing mouthwash or a saline on the day when they receive treatment for pharyngeal gonorrhoea. The primary outcome is the proportion of cases who test positive for pharyngeal gonorrhoea by culture after gargling an alcohol-containing mouthwash.

Interventions

Participants in the intervention arm will be asked to rinse and gargle a 20 mL alcohol-based mouthwash (i.e. Listerine) for 60 seconds under direct observation with a stopwatch before they receive standard treatment for pharyngeal gonorrhoea on the day. The standard treatment for pharyngeal gonorrhoea is Ceftriaxone 500mg in 2mL of 1% lignocaine as a single intramuscular injection plus a single dose of oral capsule Azithromycin 1 gram. All participants will be asked to rinse and gargle once only

Participants in the intervention arm will be asked to rinse and gargle a 20 mL alcohol-based mouthwash (i.e. Listerine) for 60 seconds under direct observation with a stopwatch before they receive standard treatment for pharyngeal gonorrhoea on the day. The standard treatment for pharyngeal gonorrhoea is Ceftriaxone 500mg in 2mL of 1% lignocaine as a single intramuscular injection plus a single dose of oral capsule Azithromycin 1 gram. All participants will be asked to rinse and gargle once only, and no follow-ups and adherence to the intervention is required in this study.

Sponsors

Alfred Health
Lead SponsorHospital

Study design

Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Prevention
Masking
Open (masking not used)

Eligibility

Sex/Gender
Male
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Men who have sex with another men in the past 12 months. Men who have a positive throat N. gonorrhea (GC) on nucleic acid amplification tests (NAATs)

Exclusion criteria

Men who had been treated prior to result for gonorrhoea with the standard treatment of Ceftriaxone 500 mg as a single dose. Men treated with Azithromycin 7 days prior

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 28, 2026