Mouthwash as a treatment for oropharyngeal gonorrhoea

Phase 2

• Conditions: Gonorrhoea; Infection - Sexually transmitted infections

• Registration Number: ACTRN12618001380280
• Lead Sponsor: The Alfred

Brief Summary

This is the first clinical trial examining the effectiveness of antiseptic mouthwash for the treatment of oropharyngeal gonorrhoea. We found that a 14-day course of antiseptic mouthwash twice a day with rinsing, gargling, and spraying was not an effective treatment with 80% of cases failing treatment.

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-08-16
• Study Completion: 2020-01-22
• Last Update Posted: 8 November 2021

Recruitment & Eligibility

• Status: Stopped early
• Sex: Male
• Target Recruitment: 12

Inclusion Criteria

(a) Males who are at the age of 16 years or above; and
(b) Have a positive test result for oropharyngeal gonorrhoea by NAAT and return to MSHC for treatment within 7 days since screening; and
(c) Provide written informed consent; and
(d) Have sufficient English language proficiency to understand the study requirements; and
(e) Willing to comply with all requirements of the study.

Exclusion Criteria

(a) Individuals who are females (to avoid the risk of developing pelvic inflammatory diseases); OR
(b) Individuals who self-identified themselves as sex workers; OR
(c) Any antibiotics use within 4 weeks prior to the day of enrolment; OR
(d) Have a positive test result for urethral gonorrhoea and/or rectal gonorrhoea on the day of screening; OR
(e) Have a positive test result for other STI such as chlamydia and syphilis on the day of screening; OR
(f) Self-report contraindications to mouthwash such as allergy; OR
(g) Travelling (including interstate/overseas) in the next 4 weeks after enrolment; OR
(h) Concurrent participation in other clinical trials that involve other medications such as the OMEGA, RTS, except PrEPX; OR
(i) Participants who know someone in their household who is currently enrolled in the OMEGA or OMEGA2 study. This is to prevent mixing the allocated mouthwashes between participants; OR
(j) Other reasons in the opinion of the investigators that should preclude the participant from the study.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The proportion of participants who have oropharyngeal gonorrhoea detected by nucleic acid amplification test (NAAT) at Week 2 in any specimen (saliva and/or oropharyngeal swabs).[Week 2.<br><br>Participants will be required to attend the clinic at week 2. Oropharyngeal swabs and a saliva sample will be taken by the clinician at week 2, and participants will receive their results within 2-3 days, as is clinic standard. ]

Secondary Outcome Measures

Name	Time	Method
The proportion of participants who have oropharyngeal gonorrhoea detected by culture[Week 2];The proportion of participants who have oropharyngeal gonorrhoea detected by NAAT/culture in any specimens[Week 4];Level of adherence to intervention regimen (self-reported)[Week 2];Feasibility of mouthwash regimen as a treatment option, as measured by self-reported willingness to use mouthwash over antibiotics[Week 4]