Trial registered on ANZCTR


Trial ID
ACTRN12615000716561
Ethics application status
Approved
Date submitted
22/06/2015
Date registered
10/07/2015
Date last updated
11/02/2016
Type of registration
Retrospectively registered

Titles & IDs
Public title
A randomised trial of alcohol-containing mouthwash or saline for pharyngeal gonorrhoea among men who have sex with men
Scientific title
Will the use of alcohol-containing mouthwash reduce pharyngeal gonorrhoea among men who have sex with men compared to who use saline?
Secondary ID [1] 286957 0
None
Universal Trial Number (UTN)
Trial acronym
GONE: Gonorrhoea Eradication
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gonorrhoea 295350 0
Condition category
Condition code
Infection 295619 295619 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants in the intervention arm will be asked to rinse and gargle a 20 mL alcohol-based mouthwash (i.e. Listerine) for 60 seconds under direct observation with a stopwatch before they receive standard treatment for pharyngeal gonorrhoea on the day. The standard treatment for pharyngeal gonorrhoea is Ceftriaxone 500mg in 2mL of 1% lignocaine as a single intramuscular injection plus a single dose of oral capsule Azithromycin 1 gram. All participants will be asked to rinse and gargle once only, and no follow-ups and adherence to the intervention is required in this study.
Intervention code [1] 292159 0
Prevention
Intervention code [2] 292160 0
Treatment: Other
Comparator / control treatment
Participants in the control arm will be asked to rinse and gargle a 20 mL saline for 60 seconds under direct observation with a stopwatch before they receive standard treatment for pharyngeal gonorrhoea on the day. The standard treatment for pharyngeal gonorrhoea is Ceftriaxone 500mg in 2mL of 1% lignocaine as a single intramuscular injection plus Azithromycin 1 gram as a single dose. All participants will be asked to rinse and gargle once only, and no follow-ups and adherence to the intervention is required in this study.
Control group
Placebo

Outcomes
Primary outcome [1] 295333 0
Primary Outcome: Proportion of pharyngeal gonorrhoea positive by culture at the tonsils. Testing will be ascertained from MSHC.
Timepoint [1] 295333 0
At the day of randomisation. Pharyngeal swabs will be taken by the clinicians before rinse/gargle, and 5 minutes after rinse/gargle. No follow-ups is required in this study.
Secondary outcome [1] 315371 0
Proportion of pharyngeal gonorrhoea positive by culture at the posterior pharynx. Testing will be ascertained from MSHC
Timepoint [1] 315371 0
At the day of randomisation. Pharyngeal swabs will be taken by the clinicians before rinse/gargle, and 5 minutes after rinse/gargle. No follow-ups is required in this study.
Secondary outcome [2] 315688 0
Acceptability of using alcohol-based mouthwash as a preventive intervention for pharyngeal gonorrhoea. This will be assessed using questionnaire. This questionnaire is designed by the principal investigator and has been reviewed and revised by several associate investigators.
Timepoint [2] 315688 0
At the day of randomisation. Participants will be asked to complete a questionnaire including questions on their recent sexual behaviours, general information on the use of mouthwash, and the acceptability of possible preventative and intervention options to prevent against pharyngeal gonorrhoea. The questionnaire will take approximately 5 minutes and will be given to participants in a hard copy format. No follow-ups is required in this study. The outcome will be assessed before the intervention.

Eligibility
Key inclusion criteria
Men who have sex with another men in the past 12 months.
Men who have a positive throat N. gonorrhea (GC) on nucleic acid amplification tests (NAATs)
Minimum age
18 Years
Maximum age
No limit
Gender
Males
Can healthy volunteers participate?
No
Key exclusion criteria
Men who had been treated prior to result for gonorrhoea with the standard treatment of Ceftriaxone 500 mg as a single dose.
Men treated with Azithromycin 7 days prior

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A researcher who is not involved in this trail will out the group allocations into 60 sealed and opaque envelopes. All sealed envelopes will be locked in an office, with access restricted to the study team, and sequentially taken for each new recruit. The coordinator recruiting patients will be unaware of the study group until the envelope is opened in front of the patient. Patients in both groups (i.e. Listerine or saline) will receive standard treatment straight after the second pharyngeal swab was taken.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A simple 1:1 randomisation in blocks will be used to ensure equal numbers in each arm of the trail. The sequence will be generated by computer software (i.e. Stata).
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis
We have assumed that we would recruit about 75% of men who are diagnosed with pharyngeal gonorrhoea to the intervention study. If we assume alcohol-containing mouthwash can reduce the proportion of cases who have a positive pharyngeal culture by 50% (from 80% to 40%) we would need 28 individuals in each arm or 56 individuals in total in the intervention study at 80% power with a 2-side significance level of alpha=0.05. We would like to round the sample size (n=56) to the nearest 10 (n=60) with 30 in each arm because there will be a very small proportion of participants are willing to take the intervention but may not be willing to complete the questionnaire.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Anticipated
Actual
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment postcode(s) [1] 9862 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 291512 0
Government body
Name [1] 291512 0
National Health and Medical Research Council
Address [1] 291512 0
Level 1, 16 Marcus Clarke Street, Canberra, ACT 2601
Country [1] 291512 0
Australia
Primary sponsor type
Hospital
Name
Alfred Health
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 290193 0
None
Name [1] 290193 0
Address [1] 290193 0
Country [1] 290193 0
Other collaborator category [1] 278501 0
University
Name [1] 278501 0
Monash University
Address [1] 278501 0
99 Commercial Road Melbourne, VIC 3004
Country [1] 278501 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 293053 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 293053 0
The Alfred, PO Box 315, Prahran Victoria 3181
Ethics committee country [1] 293053 0
Australia
Date submitted for ethics approval [1] 293053 0
25/11/2014
Approval date [1] 293053 0
05/01/2015
Ethics approval number [1] 293053 0
544/14

Summary
Brief summary
Men who have sex with men tested positive for pharyngeal gonorrhoea at Melbourne Sexual Health Centre (MSHC) who volunteer will be randomised to receive an alcohol-containing mouthwash or a saline on the day when they receive treatment for pharyngeal gonorrhoea. The primary outcome is the proportion of cases who test positive for pharyngeal gonorrhoea by culture after gargling an alcohol-containing mouthwash.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 58158 0
Dr Eric Chow
Address 58158 0
Melbourne Sexual Health Centre,
580 Swanston Street, Carlton, VIC 3053
Country 58158 0
Australia
Phone 58158 0
+61393416233
Fax 58158 0
Email 58158 0
echow@mshc.org.au
Contact person for public queries
Name 58159 0
Dr Sandy Walker
Address 58159 0
Melbourne Sexual Health Centre,
580 Swanston Street, Carlton, VIC 3053
Country 58159 0
Australia
Phone 58159 0
+61393416247
Fax 58159 0
Email 58159 0
SWalker@mshc.org.au
Contact person for scientific queries
Name 58160 0
Dr Eric Chow
Address 58160 0
Melbourne Sexual Health Centre,
580 Swanston Street, Carlton, VIC 3053
Country 58160 0
Australia
Phone 58160 0
+61393416233
Fax 58160 0
Email 58160 0
echow@mshc.org.au