Condition category
Infections and Infestations
Date applied
08/10/2002
Date assigned
08/10/2002
Last edited
07/03/2008
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

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 measures

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

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

http://www.unimelb.edu.au

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

professional associations and societies

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

Results - basic reporting

Publication summary

Protocol on http://www.ncbi.nlm.nih.gov/pubmed/15046642

Publication citations

  1. 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.

Additional files

Editorial Notes