Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12618001380280
Ethics application status
Approved
Date submitted
15/08/2018
Date registered
16/08/2018
Date last updated
2/11/2021
Date data sharing statement initially provided
8/06/2021
Date results provided
8/06/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Mouthwash as a treatment for oropharyngeal gonorrhoea
Scientific title
Mouthwash as a treatment for oropharyngeal gonorrhoea: an open-label randomised controlled trial
Secondary ID [1] 295816 0
None
Universal Trial Number (UTN)
Trial acronym
OMEGA 2 (Oral Mouthwash use to Eradicate GonorrhoeA 2)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gonorrhoea 309254 0
Condition category
Condition code
Infection 308126 308126 0 0
Sexually transmitted infections

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will receive two 500mL bottles of study mouthwash containing no alcohol, in a plain bottle labelled with their allocated study ID. This mouthwash is available at supermarkets and chemists. The participants are required to use the study mouthwash at least two times a day over a 14-days period, and will be asked to rinse, gargle, and spray the study mouthwash each time. Participants are recommended to use 10 mL each time and to rinse for 15 seconds, and gargle for 15 seconds for each use. They will also be asked to use the spray bottle provided to spray the study mouthwash 10 times to the back of their throat before spitting it out. Participants will be asked not to kiss, or to have sex with anyone for 14-days.

Adherence to the intervention regimen will be monitored in two ways: Firstly, the participants will be asked to return the used study mouthwash bottles, so remaining amounts can be measured and noted. Secondly, participants will fill out a self-reported questionnaire at the week 2 visit, asking about adherence, and sexual practices during the past 2-week period.
Intervention code [1] 312145 0
Treatment: Other
Comparator / control treatment
Participants allocated to the control group will receive the standard of care (antibiotic treatment) as per clinical management guidelines at the Melbourne Sexual Health Centre – A single intramuscular injection of 500mg ceftriaxone, plus a single dose of 1g azithromycin. These medications are approved in Australia to treat gonorrhoea. Participants will be asked not to kiss or have sex with anyone for 14 days

Control participants will also be monitored through clinic visits at week 2 and 4, where they will fill out a questionnaire.
Control group
Active

Outcomes
Primary outcome [1] 307106 0
The proportion of participants who have oropharyngeal gonorrhoea detected by nucleic acid amplification test (NAAT) at Week 2 in any specimen (saliva and/or oropharyngeal swabs).
Timepoint [1] 307106 0
Week 2.

Participants will be required to attend the clinic at week 2. Oropharyngeal swabs and a saliva sample will be taken by the clinician at week 2, and participants will receive their results within 2-3 days, as is clinic standard.
Secondary outcome [1] 350704 0
The proportion of participants who have oropharyngeal gonorrhoea detected by culture
Timepoint [1] 350704 0
Week 2
Secondary outcome [2] 350746 0
The proportion of participants who have oropharyngeal gonorrhoea detected by NAAT/culture in any specimens
Timepoint [2] 350746 0
Week 4
Secondary outcome [3] 350747 0
Level of adherence to intervention regimen (self-reported)
Timepoint [3] 350747 0
Week 2
Secondary outcome [4] 350748 0
Feasibility of mouthwash regimen as a treatment option, as measured by self-reported willingness to use mouthwash over antibiotics
Timepoint [4] 350748 0
Week 4

Eligibility
Key inclusion criteria
(a) Males who are at the age of 16 years or above; and
(b) Have a positive test result for oropharyngeal gonorrhoea by NAAT and return to MSHC for treatment within 7 days since screening; and
(c) Provide written informed consent; and
(d) Have sufficient English language proficiency to understand the study requirements; and
(e) Willing to comply with all requirements of the study.
Minimum age
16 Years
Maximum age
No limit
Sex
Males
Can healthy volunteers participate?
No
Key exclusion criteria
(a) Individuals who are females (to avoid the risk of developing pelvic inflammatory diseases); OR
(b) Individuals who self-identified themselves as sex workers; OR
(c) Any antibiotics use within 4 weeks prior to the day of enrolment; OR
(d) Have a positive test result for urethral gonorrhoea and/or rectal gonorrhoea on the day of screening; OR
(e) Have a positive test result for other STI such as chlamydia and syphilis on the day of screening; OR
(f) Self-report contraindications to mouthwash such as allergy; OR
(g) Travelling (including interstate/overseas) in the next 4 weeks after enrolment; OR
(h) Concurrent participation in other clinical trials that involve other medications such as the OMEGA, RTS, except PrEPX; OR
(i) Participants who know someone in their household who is currently enrolled in the OMEGA or OMEGA2 study. This is to prevent mixing the allocated mouthwashes between participants; OR
(j) Other reasons in the opinion of the investigators that should preclude the participant from the study.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
This is an open-label randomised controlled trial. An independent biostatistician, who has no clinical input into the trial, will generate the random number sequence, which will be held by a staff member at MSHC. The randomisation sequence will be computer generated using a block size of 4.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
A randomisation ratio of 1:1 with no stratification will be used. The sequence will be generated by computer software (i.e. Stata). The staff member will place the allocated treatment arm (either ‘antibiotics’ or ‘mouthwash’) into a sealed and opaque envelope (one per envelope). These envelopes will be labelled as per the allocation sequence (this will also be the unique number of the study participant). After performing the screening and eligibility assessments, the research nurse will open a sealed, numbered, opaque envelope containing the allocation of the treatment arm.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be analysed using a statistical package such as Stata. An intention to treat analysis will be conducted.

The demographic characteristics and sexual risk behaviours will be compared between the control and intervention arm to ensure the balance in the baseline characteristics in both arms.

Primary Analysis: The primary end-point will be the proportion of participants who have oropharyngeal gonorrhoea detected by NAAT at Week 2 in any specimen (saliva and/or oropharyngeal swabs). The 95% confidence intervals (CI) of the proportion of participants with oropharyngeal gonorrhoea will be calculated based on the ‘exact’ binomial confidence intervals. Proportions will be compared between intervention and control groups using chi-square test and logistic regression model

Secondary Analysis: The proportion of participants who have oropharyngeal gonorrhoea detected by culture at Week 2, and the proportion of participants who have oropharyngeal gonorrhoea detected by NAAT/culture in any specimens at Week 4

Our previous trial has shown that 50% of untreated MSM with oropharyngeal gonorrhoea were clear 5 minutes after a single dose of mouthwash. By increasing the dosage, it is expected that the clearance rate would increase close to 100%. Having 100 participants in each arm will provide a good sample for confidence intervals around zero.

Recruitment
Recruitment status
Stopped early
Data analysis
Data analysis is complete
Reason for early stopping/withdrawal
Participant recruitment difficulties
Safety concerns
Date of first participant enrolment
Anticipated
3/09/2018
Actual
27/09/2018
Date of last participant enrolment
Anticipated
31/12/2019
Actual
17/01/2020
Date of last data collection
Anticipated
31/01/2020
Actual
22/01/2020
Sample size
Target
200
Accrual to date
Final
12
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 11677 0
Melbourne Sexual Health Centre (MSHC) - Carlton
Recruitment postcode(s) [1] 23715 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 300411 0
Government body
Name [1] 300411 0
National Health and Medical Research Council (NHMRC)
Country [1] 300411 0
Australia
Primary sponsor type
Hospital
Name
The Alfred
Address
55 Commercial Rd, Melbourne VIC 3004
Country
Australia
Secondary sponsor category [1] 299871 0
None
Name [1] 299871 0
Address [1] 299871 0
Country [1] 299871 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 301216 0
Alfred Hospital Human Research Ethics Committee
Ethics committee address [1] 301216 0
Ethics committee country [1] 301216 0
Australia
Date submitted for ethics approval [1] 301216 0
27/03/2018
Approval date [1] 301216 0
30/04/2018
Ethics approval number [1] 301216 0
153/18

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 86258 0
A/Prof Eric Chow
Address 86258 0
Melbourne Sexual Health Centre
580 Swanston Street, Carlton, VIC 3053
Country 86258 0
Australia
Phone 86258 0
+61393416233
Fax 86258 0
Email 86258 0
[email protected]
Contact person for public queries
Name 86259 0
Eric Chow
Address 86259 0
Melbourne Sexual Health Centre
580 Swanston Street, Carlton, VIC 3053
Country 86259 0
Australia
Phone 86259 0
+61393416233
Fax 86259 0
Email 86259 0
[email protected]
Contact person for scientific queries
Name 86260 0
Eric Chow
Address 86260 0
Melbourne Sexual Health Centre
580 Swanston Street, Carlton, VIC 3053
Country 86260 0
Australia
Phone 86260 0
+61393416233
Fax 86260 0
Email 86260 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This is not covered under the current ethics approval.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
SourceTitleYear of PublicationDOI
EmbaseAn open-label, parallel-group, randomised controlled trial of antiseptic mouthwash versus antibiotics for oropharyngeal gonorrhoea treatment (OMEGA2).2020https://dx.doi.org/10.1038/s41598-020-76184-1
N.B. These documents automatically identified may not have been verified by the study sponsor.