Contact information
Type
Scientific
Primary contact
Dr Jane Gunn
ORCID ID
Contact details
Department of General Practice
200 Berkeley Street
Carlton
3053
Australia
+61 (0)3 8344 4530
j.gunn@unimelb.edu.au
Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
2001/524 (number assigned by the Therapeutic Goods Administration in Australia)
Study information
Scientific title
Acronym
PAV (post-antibiotic vulvovaginitis)
Study hypothesis
This study aims to test in a randomised controlled trial whether oral and/or vaginal lactobacillus preparations can prevent post-antibiotic vulvovaginitis.
Ethics approval
The trial has received ethics approval from both the Royal Australian College of General Practitioners and the Royal Women's Hospital, Melbourne, Australia.
Study design
Randomised controlled blinded 2 x 2 factorial design, with four intervention groups
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Prevention
Patient information sheet
Condition
Post-antibiotic vulvovaginitis
Intervention
Factorial design to test oral and vaginal lactobacillus species.
Intervention type
Drug
Phase
Not Specified
Drug names
Lactobacillus
Primary outcome measure
The primary outcome is symptomatic vulvovaginal candidiasis, defined as:
1. Participants' report of symptoms (that is answer 'yes' to a question about symptoms of 'thrush' in survey 2: vaginal itch, irritation with or without a discharge)
2. Swab B culture positive for Candida species
Secondary outcome measures
No secondary outcome measures
Overall trial start date
01/07/2004
Overall trial end date
31/12/2005
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Women aged between 18 and 50 years of age
2. Who are experiencing a non-genital infection
3. Rrequiring a short-course of oral antibiotics or have commenced this within the 48 hours preceding enrolment
4. English-speaking: able to speak, read and write in English sufficiently to provide informed consent and complete surveys
Participant type
Patient
Age group
Adult
Gender
Female
Target number of participants
496
Participant exclusion criteria
1. Pregnancy
2. Experiencing any vaginal symptoms at recruitment
3. Unwilling or unable to provide two self-collected low vaginal swabs (at recruitment and on completion of trial)
4. Using or have used vaginal antifungal treatments in the past two weeks
5. Have taken antibiotics in the past month
6. Unwilling to stop taking other lactobacillus products during the trial
7. Immunocompromised, as there are rare reports in the literature of lactobacilli causing endocarditis and bacteraemia
Recruitment start date
01/07/2004
Recruitment end date
31/12/2005
Locations
Countries of recruitment
Australia
Trial participating centre
Department of General Practice
Carlton
3053
Australia
Sponsor information
Organisation
University of Melbourne (Australia)
Sponsor details
-
Victoria
3010
Australia
Sponsor type
University/education
Website
Funders
Funder type
Charity
Funder name
Shepherd Foundation (Australia)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
Royal Australian College of General Practitioners (Australia) (ref: 00/58)
Alternative name(s)
RACGP
Funding Body Type
private sector organisation
Funding Body Subtype
Associations and societies (private and public)
Location
Australia
Funder name
Department of Health and Aged Care (Australia) - scholarship for Dr Pirotta
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Basic results (scientific)
Publication list
Protocol on http://www.ncbi.nlm.nih.gov/pubmed/15046642
Publication citations
-
Protocol
Pirotta M, Gunn J, Chondros P, Grover S, Hurley S, Garland S, The PAV trial: does lactobacillus prevent post-antibiotic vulvovaginal candidiasis? Protocol of a randomised controlled trial [ISRCTN24141277]., BMC Fam Pract, 2004, 5, 5, doi: 10.1186/1471-2296-5-5.