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Trial registered on ANZCTR


Registration number
ACTRN12617001302347
Ethics application status
Approved
Date submitted
6/09/2017
Date registered
11/09/2017
Date last updated
11/09/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Pilot study to determine the acceptability and tolerability of male partner treatment in women with bacterial vaginosis (BV)
Scientific title
Combined oral and topical antimicrobial therapy for male partners of women with bacterial vaginosis: acceptability, tolerability and impact on the genital microbiota of couples
Secondary ID [1] 292826 0
Nil
Universal Trial Number (UTN)
Not applicable
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial vaginosis 304655 0
Condition category
Condition code
Infection 303977 303977 0 0
Sexually transmitted infections
Renal and Urogenital 303993 303993 0 0
Other renal and urogenital disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Women with BV received standard treatment for their bacterial vaginosis (oral metronidazole 400 mg twice daily for seven days or 2% vaginal clindamycin cream as one applicator vaginally for seven nights if metronidazole was contraindicated or declined).

Male partners received oral metronidazole 400mg twice daily and 2% clindamycin cream applied topically to the head of the penis and upper shaft (under the foreskin if uncircumcised) twice daily for seven days.

Adherence and side effects to treatment were self-reported by participants in a questionnaire on day 8 at the end of the treatment period.
Intervention code [1] 299073 0
Treatment: Drugs
Comparator / control treatment
No control group
Control group
Uncontrolled

Outcomes
Primary outcome [1] 303313 0
The primary outcome was to assess male participant acceptability and tolerability of treatment. This was a composite primary outcome. Participants self-reported adherence to treatment and any side effects experienced at day 8. These data were used as a measure of acceptability and tolerability of treatment.
Timepoint [1] 303313 0
Day 8 - at the end of treatment period
Secondary outcome [1] 338612 0
The secondary outcome was the impact of dual-partner treatment on the genital microbiota of couples. The genital microbiota was characterized using 16S rRNA gene sequencing. Changes in the composition of the genital microbiota was assessed using Bray-Curtis scores. Changes in bacterial diversity as well as changes in the abundance and prevalence of specific bacteria was also measured. We looked at the immediate effect of treatment by comparing the microbiota at day 0 to day 8 as well as the sustained effect of treatment by comparing the microbiota at day 0 to day 28.
Timepoint [1] 338612 0
Baseline (day 0), day 8 and day 28.

Eligibility
Key inclusion criteria
Women are eligible if they:
i) Are 18-55 years of age,
ii) Have symptomatic BV (defined as a Nugent score of 4-10 and 3-4 Amsel criteria) and being treated with either oral metronidazole 400 mg twice daily for seven days or 2% vaginal clindamycin cream as one applicator vaginally for seven nights if metronidazole was contraindicated or declined.
iii) Have a single regular male partner who was willing to be enrolled in the trial.
iv) they were willing and able to comply with the protocol requirements
v) they are willing and able to comply with the protocol requirements

Males are eligible if:
i) their female partner meets the eligibility criteria
ii) they are willing and able to comply with the protocol requirements
Minimum age
18 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Women will be ineligible if they are:
i) known to be HIV positive,
ii) pregnant or breastfeeding,
iii) concurrently diagnosed with pelvic inflammatory disease (PID)
iv) allergic to study medication
v) had other concurrent sexual partners

Males will be ineligible if they are:
i) HIV positive
ii) allergic to metronidazole and/or clindamycin
iii) had other concurrent sexual partners

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
NA
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
NA
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis
The proportion of females and males who were retained in the study and who adhered to medication was calculated. Comparisons of log-transformed bacterial loads between specimen types were made using Welch’s t-test, and between paired specimens using the paired t-test.

Bray-Curtis scores were calculated between paired specimens from each participant to investigate the immediate and sustained effect of treatment on the composition of the vagina and cutaneous penile microbiota.

Changes in the prevalence and abundance of specific bacterial taxa between pre and post treatment specimens were assessed by McNemar’s chi-squared test and the Wilcoxon signed-rank test, respectively.



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
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 8964 0
The Alfred - Prahran
Recruitment postcode(s) [1] 17336 0
3053 - Carlton

Funding & Sponsors
Funding source category [1] 297456 0
University
Name [1] 297456 0
Monash University
Address [1] 297456 0
Monash University
Wellington Road, Clayton
Victoria 3800
Country [1] 297456 0
Australia
Primary sponsor type
University
Name
Monash University
Address
Monash University
Wellington Road, Clayton
Victoria 3800
Country
Australia
Secondary sponsor category [1] 296453 0
None
Name [1] 296453 0
Address [1] 296453 0
Country [1] 296453 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 298562 0
Alfred Health Human Research Ethics Committee
Ethics committee address [1] 298562 0
The Alfred
Old Baker Building, Level 1,
55 Commercial Rd, Melbourne VIC 3004
Ethics committee country [1] 298562 0
Date submitted for ethics approval [1] 298562 0
25/06/2015
Approval date [1] 298562 0
02/07/2015
Ethics approval number [1] 298562 0
264/15

Summary
Brief summary
OVERALL AIM: This pilot study aims to determine the feasibility and acceptability of treatment of male partners of women with bacterial vaginosis (BV).

OTHER AIMS: To examine the impact of dual partner treatment (male and female treatment) for BV on BV-associated bacteria on the male and female genitalia for 1 month after treatment.

BACKGROUND AND SIGNIFICANCE: BV is the most common cause of abnormal vaginal discharge in women of reproductive age affecting between 12-30% of women, suggesting it may currently affect at least 1 million Australian women. It can be associated with important complications such as miscarriage, premature birth, low birth weight, pelvic infection, and increased risk of HIV and sexually transmitted infections.

We have shown that BV recurrence (getting the infection back again) in women is common even after they take the recommended antibiotic treatment. A number of investigators have shown that BV-associated bacteria (BVAB) are present in male partners of women with BV on the penile skin and also at the end of the urethra (the tube you pee through), but male partner treatment is not currently recommended by current treatment guidelines. Studies of recurrent BV indicate that reinfection from sexual partners may be contributing to the high rates of recurrence but this requires more evaluation.

Metronidazole and topical clindamycin are both antibiotics approved for use in Australia to treat BV in women. As BV has not previously been thought to affect men they have not been licensed for use to treat BV in men. Metronidazole is however a commonly used antibiotic in men and women and has been approved for use for many conditions affecting men and women, including gastroenteritis, abscesses, dental infections and types of pneumonia, to list a few. There is extensive experience in using it in men for these other conditions. Topical clindamycin cream has not been approved for use for any conditions in men; however men may get exposed to the cream if they are having sexual intercourse with their partner while she is using the cream to treat BV. Clindamycin cream and oral metronidazole are therefore considered is an experimental treatment for BV in men. This means that they are being tested to see if they are an effective treatment to get rid of BV-associated bacteria in men.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 77478 0
A/Prof Catriona Bradshaw
Address 77478 0
Melbourne Sexual Health Centre
Alfred Health
580 Swanston St
Carlton Victoria, 3053
Country 77478 0
Australia
Phone 77478 0
+61 3 9341 6253
Fax 77478 0
+61 3 9347 6757
Email 77478 0
CBradshaw@mshc.org.au
Contact person for public queries
Name 77479 0
A/Prof Catriona Bradshaw
Address 77479 0
Melbourne Sexual Health Centre
Alfred Health
580 Swanston St
Carlton Victoria, 3053
Country 77479 0
Australia
Phone 77479 0
+61 3 9341 6253
Fax 77479 0
+61 3 9347 6757
Email 77479 0
CBradshaw@mshc.org.au
Contact person for scientific queries
Name 77480 0
A/Prof Catriona Bradshaw
Address 77480 0
Melbourne Sexual Health Centre
Alfred Health
580 Swanston St
Carlton Victoria, 3053
Country 77480 0
Australia
Phone 77480 0
+61 3 9341 6253
Fax 77480 0
+61 3 9347 6757
Email 77480 0
CBradshaw@mshc.org.au

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary