Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12607000350426
Ethics application status
Approved
Date submitted
20/06/2007
Date registered
28/06/2007
Date last updated
10/02/2012
Type of registration
Prospectively registered

Titles & IDs
Public title
Bacterial Vaginosis Antibiotic Probiotic Study
Scientific title
A randomised placebo-controlled trial to test the addition of vaginal clinidamycin or probiotic to oral metronidazole in the treatment of bacterial vaginosis
Secondary ID [1] 279757 0
None
Universal Trial Number (UTN)
Trial acronym
(BVAPS)
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Bacterial vaginosis (BV) 1907 0
Condition category
Condition code
Reproductive Health and Childbirth 1998 1998 0 0
Other reproductive health and childbirth disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
3 armed trial. All women received 400mg twice daily oral metronidazole for 7 days, and concurrently randomised to also receive either vaginal topical 2% clindamycin cream (1 applicator full once daily for 7 days); vaginal topical probiotic (L.acidophilus KS400)/0.03mg oestriol pessary (one pessary once daily for 12 days) or placebo pessary (one pessary once daily for 12 days).
Intervention code [1] 1839 0
Treatment: Drugs
Comparator / control treatment
In addition to 400mg twice daily oral metronidazole for 7 days which all participants received, women in th eplacebo arm also received a vaginal placebo pessary (once daily for 12 nights). The placebo consisted of: Lactose DC, Dibasic sodium phosphate (anhydrous), Microcrystalline cellulose, sodium starch glycolate (Type A), and magnesium stearate. The placebo pessary was indentical in appearance and composition to the active pessary with the exception of no active probioic organisms and no oestriol.
Control group
Placebo

Outcomes
Primary outcome [1] 2820 0
Recurrence of bacterial vaginosis over six months
Timepoint [1] 2820 0
Monitored at 1, 2, 3 and 6 months or at time of recurrence.
Secondary outcome [1] 4753 0
Factors associated with bacterial vaginosis recurrence, such as new sexual partner or vaginal douching.
Timepoint [1] 4753 0
Monitored at 1, 2, 3 and 6 months or at time of recurrence.

Eligibility
Key inclusion criteria
Women with BV on Nugent's criteria
Minimum age
18 Years
Maximum age
45 Years
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Pregnant, Human Immunodeficiency Virus (HIV)

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)
An independent researcher will generate and hold a randomisation sequence. A research nurse will enrol participants and use the next numbered envelope to obtain the participants unique randomised controlled trial (RCT) number, which will also identify her intervention medications.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
An independent researcher will use a computer to generate a random sequence, block randomised in groups.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
The following groups will be blinded in this study: treating clinicians; all research staff involved in recruitment and data handling and analysis; and laboratory staff responsible for asessing the main trial outcome.
Phase
Phase 3 / Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/09/2007
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 2139 0
Government body
Name [1] 2139 0
National Health and Medical Reserach Council (NHMRC) Grant
Country [1] 2139 0
Australia
Primary sponsor type
Hospital
Name
Bayside Health
Address
P.O Box 315
Prahran. Vic. 3181.
Country
Australia
Secondary sponsor category [1] 1943 0
None
Name [1] 1943 0
NA
Address [1] 1943 0
Country [1] 1943 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 3935 0
Melbourne Sexual Health Centre (Bayside Health)
Ethics committee address [1] 3935 0
Ethics committee country [1] 3935 0
Australia
Date submitted for ethics approval [1] 3935 0
Approval date [1] 3935 0
Ethics approval number [1] 3935 0

Summary
Brief summary
To determine if the addition of either topical clindamycin or a topical probiotic/oestrogen combination, reduces recurrent rates of bacterial vaginosis (BV), when added to the current recommended therapy of seven days of the oral antibiotic metronidazole.
Hypotheses
1. Combination antibiotic therapy of oral metronidazole with vaginal clindamycin will be more effective than oral metronidazole alone in the treatment of bacterial vaginosis.
2. Restoring normal vaginal acidity and healthy bacteria through replacement of Lactobacillus bacteria and topical oestrogen (in addition to oral metronidazole), will achieve higher rates of cure than current recommended therapy oral metronidazole alone.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 27653 0
Address 27653 0
Country 27653 0
Phone 27653 0
Fax 27653 0
Email 27653 0
Contact person for public queries
Name 11028 0
Marie Pirotta
Address 11028 0
Department of General Practice
200 Berkeley Street
Carlton VIC 3053
Country 11028 0
Australia
Phone 11028 0
+61 3 83449723
Fax 11028 0
+61 3 93476136
Email 11028 0
m.pirotta@unimelb.edu.au
Contact person for scientific queries
Name 1956 0
Marie Pirotta
Address 1956 0
Department of General Practice
200 Berkeley Street
Carlton VIC 3053
Country 1956 0
Australia
Phone 1956 0
+61 3 83449723
Fax 1956 0
+61 3 93476136
Email 1956 0
m.pirotta@unimelb.edu.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
No additional documents have been identified.