None listed
Conditions
Brief summary
The aim of this study is to determine whether an antiseptic mouthwash (twice a day over a 14-days period) can be used as an alternative treatment for oropharyngeal gonorrhoea without using antibiotics. If mouthwash can be used as an alternative treatment, then it would provide a possible treatment if gonorrhoea were to become multi-resistant, something that is clearly concerning the WHO and US CDC.
Interventions
Participants will receive two 500mL bottles of study mouthwash containing no alcohol, in a plain bottle labelled with their allocated study ID. This mouthwash is available at supermarkets and chemists. The participants are required to use the study mouthwash at least two times a day over a 14-days period, and will be asked to rinse, gargle, and spray the study mouthwash each time. Participants are recommended to use 10 mL each time and to rinse for 15 seconds, and gargle for 15 seconds for each
Participants will receive two 500mL bottles of study mouthwash containing no alcohol, in a plain bottle labelled with their allocated study ID. This mouthwash is available at supermarkets and chemists. The participants are required to use the study mouthwash at least two times a day over a 14-days period, and will be asked to rinse, gargle, and spray the study mouthwash each time. Participants are recommended to use 10 mL each time and to rinse for 15 seconds, and gargle for 15 seconds for each use. They will also be asked to use the spray bottle provided to spray the study mouthwash 10 times to the back of their throat before spitting it out. Participants will be asked not to kiss, or to have sex with anyone for 14-days. Adherence to the intervention regimen will be monitored in two ways: Firstly, the participants will be asked to return the used study mouthwash bottles, so remaining amounts can be measured and noted. Secondly, participants will fill out a self-reported questionnaire at the week 2 visit, asking about adherence, and sexual practices during the past 2-week period.
Sponsors
The Alfred
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
Male
Age
16 Years to No maximum
Healthy volunteers
No
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.
Outcome results
None listed