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

Eric P.F. Chow, Sandra Walker, Jane Hocking, Catriona S. Bradshaw, Marcus Y. Chen, Sepehr N Tabrizi, Benjamin P. Howden, Matthew G. Law, Kate Maddaford, Tim R.H. Read, David A. Lewis, David M Whiley, Lei Zhang, Andrew E Grulich, John Martin Kaldor, Vincent J. Cornelisse, Samuel Phillips, Basil Donovan, Anna M McNulty, David J Templeton & 3 others Norman Roth, Richard Moore, Christopher K. Fairley

Research output: Contribution to journalArticleOtherpeer-review

18 Citations (Scopus)

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.
Original languageEnglish
Article number456
Number of pages16
JournalBMC Infectious Diseases
Volume17
DOIs
Publication statusPublished - 28 Jun 2017

Keywords

  • Gonorrhoea
  • Men who have sex with men
  • Mouthwash
  • Oropharyngeal
  • Prevention
  • Prophylaxis
  • Sexually transmitted infection
  • Throat
  • Topical antiseptics

Cite this

Chow, Eric P.F. ; Walker, Sandra ; Hocking, Jane ; Bradshaw, Catriona S. ; Chen, Marcus Y. ; Tabrizi, Sepehr N ; Howden, Benjamin P. ; Law, Matthew G. ; Maddaford, Kate ; Read, Tim R.H. ; Lewis, David A. ; Whiley, David M ; Zhang, Lei ; Grulich, Andrew E ; Kaldor, John Martin ; Cornelisse, Vincent J. ; Phillips, Samuel ; Donovan, Basil ; McNulty, Anna M ; Templeton, David J ; Roth, Norman ; Moore, Richard ; Fairley, Christopher K. / 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. In: BMC Infectious Diseases. 2017 ; Vol. 17.
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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",
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.",
keywords = "Gonorrhoea, Men who have sex with men, Mouthwash, Oropharyngeal, Prevention, Prophylaxis, Sexually transmitted infection, Throat, Topical antiseptics",
author = "Chow, {Eric P.F.} and Sandra Walker and Jane Hocking and Bradshaw, {Catriona S.} and Chen, {Marcus Y.} and Tabrizi, {Sepehr N} and Howden, {Benjamin P.} and Law, {Matthew G.} and Kate Maddaford and Read, {Tim R.H.} and Lewis, {David A.} and Whiley, {David M} and Lei Zhang and Grulich, {Andrew E} and Kaldor, {John Martin} and Cornelisse, {Vincent J.} and Samuel Phillips and Basil Donovan and McNulty, {Anna M} and Templeton, {David J} and Norman Roth and Richard Moore and Fairley, {Christopher K.}",
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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. / Chow, Eric P.F.; Walker, Sandra; Hocking, Jane ; Bradshaw, Catriona S.; Chen, Marcus Y.; Tabrizi, Sepehr N; Howden, Benjamin P.; Law, Matthew G.; Maddaford, Kate; Read, Tim R.H.; Lewis, David A.; Whiley, David M; Zhang, Lei; Grulich, Andrew E; Kaldor, John Martin; Cornelisse, Vincent J.; Phillips, Samuel; Donovan, Basil ; McNulty, Anna M; Templeton, David J; Roth, Norman; Moore, Richard; Fairley, Christopher K.

In: BMC Infectious Diseases, Vol. 17, 456, 28.06.2017.

Research output: Contribution to journalArticleOtherpeer-review

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T1 - 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

AU - Chow, Eric P.F.

AU - Walker, Sandra

AU - Hocking, Jane

AU - Bradshaw, Catriona S.

AU - Chen, Marcus Y.

AU - Tabrizi, Sepehr N

AU - Howden, Benjamin P.

AU - Law, Matthew G.

AU - Maddaford, Kate

AU - Read, Tim R.H.

AU - Lewis, David A.

AU - Whiley, David M

AU - Zhang, Lei

AU - Grulich, Andrew E

AU - Kaldor, John Martin

AU - Cornelisse, Vincent J.

AU - Phillips, Samuel

AU - Donovan, Basil

AU - McNulty, Anna M

AU - Templeton, David J

AU - Roth, Norman

AU - Moore, Richard

AU - Fairley, Christopher K.

PY - 2017/6/28

Y1 - 2017/6/28

N2 - 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.

AB - 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.

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