Eric P F Chow1, Deborah A Williamson2, Jane S Hocking3, Matthew G Law4, Kate Maddaford5, Catriona S Bradshaw6, Anna McNulty7, David J Templeton8, Richard Moore9, Gerald L Murray10, Jennifer A Danielewski10, Rebecca Wigan5, Marcus Y Chen6, Rebecca J Guy4, Lei Zhang11, Basil Donovan12, Andrew E Grulich4, John M Kaldor4, David M Whiley13, Vincent J Cornelisse14, Benjamin P Howden2, David A Lewis15, Tim R H Read6, Christopher K Fairley11. 1. Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia; Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, VIC, Australia. Electronic address: eric.chow@monash.edu. 2. Microbiological Diagnostic Unit Public Health Laboratory, Department of Microbiology and Immunology, The University of Melbourne at The Peter Doherty Institute for Infection and Immunity, Melbourne, VIC, Australia. 3. Centre for Epidemiology and Biostatistics, Melbourne School of Population and Global Health, The University of Melbourne, VIC, Australia. 4. The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia. 5. Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia. 6. Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia. 7. School of Public Health and Community Medicine, University of New South Wales Sydney, Sydney, NSW, Australia; Sydney Sexual Health Centre, South Eastern Sydney Local Health District, Sydney, NSW, Australia. 8. The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia; Department of Sexual Health Medicine, Sydney Local Health District, Sydney, NSW, Australia; Sydney Medical School, The University of Sydney, Sydney, NSW, Australia. 9. Northside Clinic, Melbourne, VIC, Australia. 10. Murdoch Children's Research Institute, Melbourne, VIC, Australia; Centre for Women's Infectious Disease Research, The Royal Women's Hospital, Melbourne, VIC, Australia. 11. Melbourne Sexual Health Centre, Alfred Health, Melbourne, VIC, Australia; Central Clinical School, Monash University, Melbourne, VIC, Australia; China-Australia Joint Research Centre for Infectious Diseases, School of Public Health, Xi'an Jiaotong University, Xi'an, China. 12. The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia; Sydney Sexual Health Centre, South Eastern Sydney Local Health District, Sydney, NSW, Australia. 13. Pathology Queensland, Brisbane, QLD, Australia; Centre for Clinical Research, The University of Queensland, Brisbane, QLD, Australia. 14. Central Clinical School, Monash University, Melbourne, VIC, Australia; The Kirby Institute, University of New South Wales Sydney, Sydney, NSW, Australia; Kirketon Road Centre, South Eastern Sydney Local Health District, Sydney, NSW, Australia. 15. Westmead Clinical School, Faculty of Medicine and Health, The University of Sydney, Sydney, NSW, Australia; Western Sydney Sexual Health Centre, Western Sydney Local Health District, Sydney, NSW, Australia; Marie Bashir Institute for Infectious Diseases and Biosecurity, The University of Sydney, Sydney, NSW, Australia.
Abstract
BACKGROUND: To address the increasing incidence of gonorrhoea and antimicrobial resistance, we compared the efficacy of Listerine and Biotène mouthwashes for preventing gonorrhoea among men who have sex with men (MSM). METHODS: The OMEGA trial was a multicentre, parallel-group, double-blind randomised controlled trial among MSM, done at three urban sexual health clinics and one general practice clinic in Australia. Men were eligible if they were diagnosed with oropharyngeal gonorrhoea by nucleic acid amplification test (NAAT) in the previous 30 days or were aged 16-24 years. They were randomly assigned to receive Listerine (intervention) or Biotène (control) via a computer-generated sequence (1:1 ratio, block size of four). Participants, clinicians, data collectors, data analysts, and outcome adjudicators were masked to the interventions after assignment. Participants were instructed to rinse and gargle with 20 mL of mouthwash for 60 s at least once daily for 12 weeks. Oropharyngeal swabs were collected by research nurses every 6 weeks, and participants provided saliva samples every 3 weeks, to be tested for Neisseria gonorrhoeae with NAAT and quantitative PCR. The primary outcome was proportion of MSM diagnosed with oropharyngeal N gonorrhoeae infection at any point over the 12-week period, defined as a positive result for either oropharyngeal swabs or saliva samples by NAAT, and the cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit. A modified intention-to-treat analysis for the primary outcome was done that included men who provided at least one follow-up specimen over the 12-week study period. The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12616000247471). FINDINGS:Between March 30, 2016, and Oct 26, 2018, 786 MSM were screened and 256 were excluded. 264 MSM were randomly assigned to the Biotène group and 266 to the Listerine group. The analysis population included 227 (86%) men in the Biotène group and 219 (82%) in the Listerine group. Oropharyngeal gonorrhoea was detected in ten (4%) of 227 of MSM in the Biotène group and in 15 (7%) of 219 in the Listerine group (adjusted risk difference 2·5%, 95% CI -1·8 to 6·8). The cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit did not differ between the two mouthwash groups (adjusted risk difference 3·1%, 95% CI -1·4 to 7·7). INTERPRETATION:Listerine did not reduce the incidence of oropharyngeal gonorrhoea compared with Biotène. However, previous research suggests that mouthwash might reduce the infectivity of oropharyngeal gonorrhoea; therefore, further studies of mouthwash examining its inhibitory effect on N gonorrhoeae are warranted to determine if it has a potential role for the prevention of transmission. FUNDING: Australian National Health and Medical Research Council.
RCT Entities:
BACKGROUND: To address the increasing incidence of gonorrhoea and antimicrobial resistance, we compared the efficacy of Listerine and Biotène mouthwashes for preventing gonorrhoea among men who have sex with men (MSM). METHODS: The OMEGA trial was a multicentre, parallel-group, double-blind randomised controlled trial among MSM, done at three urban sexual health clinics and one general practice clinic in Australia. Men were eligible if they were diagnosed with oropharyngeal gonorrhoea by nucleic acid amplification test (NAAT) in the previous 30 days or were aged 16-24 years. They were randomly assigned to receive Listerine (intervention) or Biotène (control) via a computer-generated sequence (1:1 ratio, block size of four). Participants, clinicians, data collectors, data analysts, and outcome adjudicators were masked to the interventions after assignment. Participants were instructed to rinse and gargle with 20 mL of mouthwash for 60 s at least once daily for 12 weeks. Oropharyngeal swabs were collected by research nurses every 6 weeks, and participants provided saliva samples every 3 weeks, to be tested for Neisseria gonorrhoeae with NAAT and quantitative PCR. The primary outcome was proportion of MSM diagnosed with oropharyngeal N gonorrhoeae infection at any point over the 12-week period, defined as a positive result for either oropharyngeal swabs or saliva samples by NAAT, and the cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit. A modified intention-to-treat analysis for the primary outcome was done that included men who provided at least one follow-up specimen over the 12-week study period. The trial was registered on the Australian and New Zealand Clinical Trials Registry (ACTRN12616000247471). FINDINGS: Between March 30, 2016, and Oct 26, 2018, 786 MSM were screened and 256 were excluded. 264 MSM were randomly assigned to the Biotène group and 266 to the Listerine group. The analysis population included 227 (86%) men in the Biotène group and 219 (82%) in the Listerine group. Oropharyngeal gonorrhoea was detected in ten (4%) of 227 of MSM in the Biotène group and in 15 (7%) of 219 in the Listerine group (adjusted risk difference 2·5%, 95% CI -1·8 to 6·8). The cumulative incidence of oropharyngeal gonorrhoea at the week 12 visit did not differ between the two mouthwash groups (adjusted risk difference 3·1%, 95% CI -1·4 to 7·7). INTERPRETATION:Listerine did not reduce the incidence of oropharyngeal gonorrhoea compared with Biotène. However, previous research suggests that mouthwash might reduce the infectivity of oropharyngeal gonorrhoea; therefore, further studies of mouthwash examining its inhibitory effect on N gonorrhoeae are warranted to determine if it has a potential role for the prevention of transmission. FUNDING: Australian National Health and Medical Research Council.
Authors: Eloise Williams; Bowen Zhang; Eric P F Chow; Socheata Chea; Tiffany R Phillips; Kate Maddaford; Marcelina Krysiak; Yi Nong; Helen Stefanatos; Shivani Pasricha; Christopher K Fairley; Deborah A Wiliamson Journal: Antimicrob Agents Chemother Date: 2022-05-17 Impact factor: 5.938
Authors: Jolein G E Laumen; Christophe Van Dijck; Sheeba S Manoharan-Basil; Saïd Abdellati; Irith De Baetselier; Vicky Cuylaerts; Tessa De Block; Dorien Van den Bossche; Basil B Xavier; Surbhi Malhotra-Kumar; Chris Kenyon Journal: Front Microbiol Date: 2021-11-25 Impact factor: 5.640
Authors: Deborah A Williamson; Eric P F Chow; Erica L Plummer; Kate Maddaford; Gerald L Murray; Christopher K Fairley; Shivani Pasricha; Andre Mu; Catriona S Bradshaw Journal: Microbiol Spectr Date: 2022-01-12
Authors: Xianglong Xu; Eric P F Chow; Mingwang Shen; Zhuoru Zou; Chongjian Wang; Jason J Ong; Christopher K Fairley; Lei Zhang Journal: BMJ Open Date: 2021-10-07 Impact factor: 3.006
Authors: Zack Saud; Victoria J Tyrrell; Andreas Zaragkoulias; Majd B Protty; Evelina Statkute; Anzelika Rubina; Kirsten Bentley; Daniel A White; Patricia Dos Santos Rodrigues; Robert C Murphy; Harald Köfeler; William J Griffiths; Jorge Alvarez-Jarreta; Richard William Brown; Robert G Newcombe; James Heyman; Manon Pritchard; Robert Wj Mcleod; Arvind Arya; Ceri-Ann Lynch; David Owens; P Vince Jenkins; Niklaas J Buurma; Valerie B O'Donnell; David W Thomas; Richard J Stanton Journal: J Lipid Res Date: 2022-04-15 Impact factor: 6.676