DEVA
Research type
Research Study
Full title
Dequalinium versus usual care antibiotics for the treatment of bacterial vaginosis (DEVA): a multicentre, randomised, open label, non-inferiority trial
IRAS ID
269405
Contact name
Janet Wilson
Contact email
Sponsor organisation
Leeds Teaching Hospital NHS Trust
Eudract number
2019-002819-25
ISRCTN Number
ISRCTN91800263
Duration of Study in the UK
1 years, 11 months, 30 days
Research summary
Bacterial vaginosis (BV) causes a vaginal discharge that has an unpleasant smell. It is the most common cause of discharge and up to a third of women will get it at some time in their lives. We do not know why BV occurs but there is a change in the balance of the vaginal bacteria with a reduction in the ‘good’ bacteria that protect against infections and an increase in many other bacteria. Current treatments often do not not cure BV completely, but treating BV is important as the symptoms are unpleasant. Also, it can cause miscarriage, premature birth and it increases the risk of catching HIV and other sexually transmitted infections.
Oral or vaginal antibiotics are recommended for treating BV. These can cause side-effects such as dizziness, nausea and vaginal soreness. Over 1 in 5 women get BV back within one month of treatment and have to take repeated courses of antibiotics. Concern about bacteria becoming resistant to antibiotics and damage to the body’s good bacteria means that non-antibiotic therapies are being considered for BV.
There is a new treatment available for BV called dequalinium which works as a vaginal antiseptic. Its potential advantages are that it will not damage the good bacteria throughout the body or cause antibiotic resistance. Two studies have suggested that it could be effective and safe but the number of women included were small so the results were not conclusive. Also, dequalinium is more expensive than some of the usual care antibiotics.
The aim of this study, called DEVA, is to see if dequalinium is as good at treating BV as current BV antibiotics.
REC name
North West - Liverpool Central Research Ethics Committee
REC reference
20/NW/0113
Date of REC Opinion
22 Apr 2020
REC opinion
Further Information Favourable Opinion