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Journal article
A multicentre double-blind randomised controlled trial evaluating the efficacy of daily use of antibacterial mouthwash against oropharyngeal gonorrhoea among men who have sex with men: the OMEGA (Oral Mouthwash use to Eradicate GonorrhoeA) study protocol
BMC Infectious Diseases, Vol.17, pp.1-16
2017
PMID: 28659133
Abstract
Background
Gonorrhoea is one of the most common sexually transmissible infections in men who have sex with men (MSM). Gonorrhoea rates have increased substantially in recent years. There is concern that increasing gonorrhoea prevalence will increase the likelihood of worsening antibiotic resistance in Neisseria gonorrhoeae. A recent randomised controlled trial (RCT) demonstrated that a single-dose of mouthwash has an inhibitory effect against oropharyngeal gonorrhoea. We are conducting the first RCT to evaluate whether daily use of mouthwash could reduce the risk of acquiring oropharyngeal gonorrhoea.
Methods/design
The OMEGA (Oral Mouthwash use to Eradicate GonorrhoeA) study is a double-blind RCT and will be conducted at several sexual health clinics and high caseload General Practice (GP) clinics in Melbourne and Sydney, Australia. A total of 504 MSM attending the participating sites will be recruited. Participants will be randomised to either using ‘Study mouthwash A’ or ‘Study mouthwash B’ for 12 weeks. Study mouthwash A was inhibitory against N. gonorrhoeae in vitro, whereas study mouthwash B was not. Participants will be instructed to rinse and gargle the study mouthwash for 60 seconds every day. The primary outcome is the proportion of participants with oropharyngeal gonorrhoea detected by nucleic acid amplification test by 12 weeks.
Discussion
The results from this trial may provide a novel way to reduce gonorrhoea prevalence and transmission without the use of antibiotics that may be associated with development of resistance. If shown to be effective, the widespread use of mouthwash will reduce the prevalence of oropharyngeal gonorrhoea, which plays key role in driving the emergence of gonococcal antimicrobial resistance through DNA exchange with oral commensal bacteria. The anticipated net effect will be interruption of onward transmission of N. gonorrhoeae within high density sexual networks within MSM populations.
Trial registration
Australian New Zealand Clinical Trials Registry ACTRN12616000247471, registered on 23rd February 2016.
Details
- Title
- A multicentre double-blind randomised controlled trial evaluating the efficacy of daily use of antibacterial mouthwash against oropharyngeal gonorrhoea among men who have sex with men: the OMEGA (Oral Mouthwash use to Eradicate GonorrhoeA) study protocol
- Authors
- Eric P F Chow (Corresponding Author) - Melbourne Sexual Health CentreSandra Walker - Melbourne Sexual Health CentreJane S Hocking - The University of MelbourneCatriona S Bradshaw - Melbourne Sexual Health CentreMarcus Y Chen - Melbourne Sexual Health CentreSepehr N Tabrizi - Royal Women's HospitalBenjamin P Howden - Peter Doherty InstituteMatthew G. Law - Sydney Sexual Health CentreKate Maddaford - Alfred HealthTim R. H. Read - The Alfred HospitalDavid A. Lewis - Sydney Sexual Health CentreDavid M Whiley - Pathology QueenslandLei Zhang - Monash UniversityAndrew E Grulich - Prahran Market Clinic (Australia)John Kaldor - Prahran Market Clinic (Australia)Vincent J. Cornelisse - Monash UniversitySamuel Phillips - Royal Women's HospitalBasil Donovan - UNSW SydneyAnna McNulty - Sydney Sexual Health CentreDavid J Templeton - UNSW SydneyNorman Roth - Sydney Sexual Health CentreRichard Moore - Northside Clinic (Australia)Christopher K Fairley - Monash University
- Publication details
- BMC Infectious Diseases, Vol.17, pp.1-16
- Publisher
- BioMed Central Ltd.
- Date published
- 2017
- DOI
- 10.1186/s12879-017-2541-3
- ISSN
- 1471-2334
- PMID
- 28659133
- Copyright note
- This article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.
- Data Availability
- Not applicable. This is a study protocol and does not contain any data.
- Grant note
- This trial is supported by a National Health and Medical Research Council (NHMRC) project grant (1122514). EPFC and TRHR are supported by the Australian NHMRC Early Career Fellowships (EPFC: 1,091,226; TRHR: 1,091,536). BPH is supported by an NHMRC Practitioner Fellowship (1105905).
- Organisation Unit
- School of Health - Biomedicine; Centre for Bioinnovation
- Language
- English
- Record Identifier
- 991144232802621
- Output Type
- Journal article
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