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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]

Nil

Universal Trial Number (UTN)

Not applicable

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Bacterial vaginosis

Condition category

Condition code

Infection

Sexually transmitted infections

Renal and Urogenital

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]

Treatment: Drugs

Comparator / control treatment

No control group

Control group

Uncontrolled

Outcomes

Primary outcome [1]

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]

Day 8 - at the end of treatment period

Secondary outcome [1]

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]

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

Sex

Both males and females

Can healthy volunteers participate?

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)

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

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

18/08/2015

Date of last participant enrolment

Anticipated

Actual

22/02/2016

Date of last data collection

Anticipated

Actual

21/03/2016

Sample size

Target

Accrual to date

Final

Recruitment in Australia

Recruitment state(s)

VIC

Recruitment hospital [1]

The Alfred - Prahran

Recruitment postcode(s) [1]

3053 - Carlton

Funding & Sponsors

Funding source category [1]

University

Name [1]

Monash University

Address [1]

Monash University
Wellington Road, Clayton
Victoria 3800

Country [1]

Australia

Primary sponsor type

University

Name

Monash University

Address

Monash University
Wellington Road, Clayton
Victoria 3800

Country

Australia

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Alfred Health Human Research Ethics Committee

Ethics committee address [1]

The Alfred
Old Baker Building, Level 1,
55 Commercial Rd, Melbourne VIC 3004

Ethics committee country [1]

Date submitted for ethics approval [1]

25/06/2015

Approval date [1]

02/07/2015

Ethics approval number [1]

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

A/Prof Catriona Bradshaw

Address

Melbourne Sexual Health Centre
Alfred Health
580 Swanston St
Carlton Victoria, 3053

Country

Australia

Phone

+61 3 9341 6253

Fax

+61 3 9347 6757

CBradshaw@mshc.org.au

Contact person for public queries

Name

Catriona Bradshaw

Address

Melbourne Sexual Health Centre
Alfred Health
580 Swanston St
Carlton Victoria, 3053

Country

Australia

Phone

+61 3 9341 6253

Fax

+61 3 9347 6757

CBradshaw@mshc.org.au

Contact person for scientific queries

Name

Catriona Bradshaw

Address

Melbourne Sexual Health Centre
Alfred Health
580 Swanston St
Carlton Victoria, 3053

Country

Australia

Phone

+61 3 9341 6253

Fax

+61 3 9347 6757

CBradshaw@mshc.org.au

No information has been provided regarding IPD availability

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

Source	Title	Year of Publication	DOI
Embase	Combined oral and topical antimicrobial therapy for male partners of women with bacterial vaginosis: Acceptability, tolerability and impact on the genital microbiota of couples - A pilot study.	2018	https://dx.doi.org/10.1371/journal.pone.0190199

N.B. These documents automatically identified may not have been verified by the study sponsor.

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