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

Study Protocol

Jane S. Hocking¹  Samuel Phillips²  Sepehr N. Tabrizi³  Kate Maddaford⁴  Tim R. H. Read⁵  Eric P. F. Chow⁵  Marcus Y. Chen⁵  Sandra Walker⁵  Lei Zhang⁵  Christopher K. Fairley⁵  Catriona S. Bradshaw⁵  Vincent J. Cornelisse⁶  Benjamin P. Howden⁷  Richard Moore⁸  David M. Whiley⁹  John M. Kaldor^1,10  Andrew E. Grulich^1,10  Norman Roth^1,11  Anna M. McNulty^1,12  David J. Templeton^1,13  Basil Donovan^1,14  Matthew G. Law^1,15  David A. Lewis^1,16 

[1] Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, 3053, Melbourne, VIC, Australia;Department of Microbiology and Infectious Diseases, The Royal Women’s Hospital, 3052, Parkville, VIC, Australia;Murdoch Childrens Research Institute, 3052, Parkville, VIC, Australia;Department of Microbiology and Infectious Diseases, The Royal Women’s Hospital, 3052, Parkville, VIC, Australia;Murdoch Childrens Research Institute, 3052, Parkville, VIC, Australia;Department of Obstetrics and Gynaecology, The University of Melbourne, 3052, Parkville, VIC, Australia;Melbourne Sexual Health Centre, Alfred Health, 580 Swanston Street, 3053, Carlton, VIC, Australia;Melbourne Sexual Health Centre, Alfred Health, 580 Swanston Street, 3053, Carlton, VIC, Australia;Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, 3004, Melbourne, VIC, Australia;Melbourne Sexual Health Centre, Alfred Health, 580 Swanston Street, 3053, Carlton, VIC, Australia;Central Clinical School, Faculty of Medicine, Nursing and Health Sciences, Monash University, 3004, Melbourne, VIC, Australia;Prahran Market Clinic, 3181, Prahran, VIC, Australia;Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, The University of Melbourne, Peter Doherty Institute for Infection and Immunity, 3010, Parkville, VIC, Australia;Northside Clinic, 3068, Fitzroy North, VIC, Australia;Pathology Queensland Central Laboratory, QLD, 4029, Brisbane, Australia;The University of Queensland Centre for Clinical Research, Royal Brisbane and Women’s Hospital Campus, QLD, 4029, Herston, Australia;Prahran Market Clinic, 3181, Prahran, VIC, Australia;Sydney Sexual Health Centre, Sydney Hospital, 2000, Sydney, NSW, Australia;Sydney Sexual Health Centre, Sydney Hospital, 2000, Sydney, NSW, Australia;School of Public Health and Community Medicine, UNSW Sydney, 2052, Kensington, NSW, Australia;The Kirby Institute, UNSW Sydney, 2052, Kensington, NSW, Australia;RPA Sexual Health, Community Health, Sydney Local Health District, 2050, Camperdown, NSW, Australia;Central Clinical School, The University of Sydney, 2006, Camperdown, NSW, Australia;The Kirby Institute, UNSW Sydney, 2052, Kensington, NSW, Australia;Sydney Sexual Health Centre, Sydney Hospital, 2000, Sydney, NSW, Australia;Western Sydney Sexual Health Centre, Western Sydney Local Health District, 2150, Parramatta, NSW, Australia;Western Sydney Sexual Health Centre, Western Sydney Local Health District, 2150, Parramatta, NSW, Australia;Marie Bashir Institute for Infectious Diseases and Biosecurity & Sydney Medical School-Westmead, The University of Sydney, 2145, Westmead, NSW, Australia;

关键词: Men who have sex with men;    Sexually transmitted infection;    Gonorrhoea;    Mouthwash;    Prevention;    Oropharyngeal;    Throat;    Topical antiseptics;    Prophylaxis;   

DOI  :  10.1186/s12879-017-2541-3

 received in 2017-05-25, accepted in 2017-06-09,  发布年份 2017

来源: Springer

【 摘 要 】

BackgroundGonorrhoea 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/designThe 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.DiscussionThe 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 registrationAustralian New Zealand Clinical Trials Registry ACTRN12616000247471, registered on 23rd February 2016.

【 授权许可】

CC BY   
© The Author(s). 2017