Plain English Summary
Background and study aims
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.
Who can participate?
Women with a diagnosis of bacterial vaginosis.
What does the study involve?
Participants will be assigned to treatment groups using a remote internet-based randomization system to one of the following the intervention or control arm.
The intervention arm will receive dequalinium chloride 10mg vaginal tablet for 6 nights. This is the formulation and course that is licensed for use in the UK.
The control arm will receive usual care antibiotics. Clinician-chosen usual care antibiotic treatment selected from UK guideline-recommended or alternative oral or topical antibiotic BV treatments which (at the time of writing the protocol) will be one of the following treatments:
1. Metronidazole 400 mg orally twice daily for 5-7 days
2. Metronidazole 2 g single dose orally
3. Intravaginal metronidazole gel (0.75%) once daily for 5 days
4. Intravaginal clindamycin cream (2%) once daily for 7 days
5. Tinidazole 2 g single dose orally
6. Clindamycin 300 mg orally twice daily for 7 days
A subgroup of women in each arm, who provide informed consent to take their own vaginal swabs at home and post them to us at 4 weeks, will also be assessed for clinical diagnosis of bacterial vaginosis.
For both arms, participants will be sent confidential online questionnaires at 4 weeks and 12 weeks to ask about if symptoms have cleared, the amount of treatment used, the side effects and the acceptability of the treatment
What are the possible benefits and risks of participating?
Participants may not receive any immediate extra benefit from taking part, the research will help improve the treatments and care provided to all women with BV in the future.
As a thank you, women who participate in the study and complete the 4 week questionnaire will receive a £10 Amazon voucher and a further £5 Amazon voucher on completion of their 12 week questionnaire.
Dequalinium chloride is already used to treat episodes of BV, we still do not know if it works as well as current antibiotics. If it does not work as well, participants may need to take additional treatment to treat their BV. As with all medications, there is a small risk of side effects and with dequalinium chloride this may include vaginal candidiasis (thrush/yeast infection) and vulvovaginal discomforts such as itching and/or burning sensations. For those who are randomised to receive usual care antibiotics the side effects of those medications will be explained to the participant by the research team.
Where is the study run from?
The study is being run from Leeds Teaching Hospital NHS Trust (Genitourinary Medicine, George Street, Leeds, LS1 3EX)
When is the study starting and how long is it expected to run for?
Participants will be recruited to the study between 01/05/2020 and 01/01/2022
Who is funding the study?
National Institute for Health Research (UK)
Who is the main contact?
Mrs Rebecca Haydock, Nottingham Clinical Trials Unit, deva@nottingham.ac.uk
Trial website
Contact information
Type
Public
Primary contact
Mrs Rebecca Haydock
ORCID ID
Contact details
NCTU
Building 42
University Park
University of Nottingham
NG7 2UH
United Kingdom
01157487105
deva@nottingham.ac.uk
Additional identifiers
EudraCT number
2019-002819-25
ClinicalTrials.gov number
Nil known
Protocol/serial number
GU18/108645
Study information
Scientific title
DEqualinium versus usual care antibiotics for the treatment of bacterial VAginosis (DEVA): a multicentre randomised, open label, non-inferiority trial
Acronym
DEVA
Study hypothesis
To determine if dequalinium chloride is effective in the management of bacterial vaginosis (BV) compared to usual care antibiotics.
Ethics approval
Not provided at time of registration
Study design
Multi-centre, randomized, open-label, parallel-group, non-inferiority trial with equal allocation (1:1)
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Home
Trial type
Treatment
Patient information sheet
Not yet available in web format, please use contact details to request a participant information sheet
Condition
Bacterial Vaginosis
Intervention
Participants will be assigned to treatment groups using a remote internet-based randomization system to one of the following the intervention or control arm.
The intervention arm will receive dequalinium chloride 10mg vaginal tablet for 6 nights. This is the formulation and course that is licensed for use in the UK.
The control arm will receive usual care antibiotics. Clinician-chosen usual care antibiotic treatment selected from UK guideline recommended or alternative oral or topical antibiotic BV treatments which (at the time of writing the protocol) will be one of the following treatments:
1. Metronidazole 400 mg orally twice daily for 5-7 days
2. Metronidazole 2 g single dose orally
3. Intravaginal metronidazole gel (0.75%) once daily for 5 days
4. Intravaginal clindamycin cream (2%) once daily for 7 days
5. Tinidazole 2 g single dose orally
6. Clindamycin 300 mg orally twice daily for 7 days
A subgroup of women in each arm, who provide informed consent to take their own vaginal swabs at home and post them to us at 4 weeks, will also be assessed for clinical diagnosis of bacterial vaginosis.
For both arms, participants will be sent confidential online questionnaires at 4 weeks and 12 weeks to ask about if symptoms have cleared, the amount of treatment used, the side effects and the acceptability of the treatment
Intervention type
Drug
Phase
Phase IV
Drug names
Dequalinium Chloride
Primary outcome measure
Participant-reported resolution of bacterial vaginosis (BV) symptoms without the need for additional treatment assessed by online questionnaire at 4 weeks.
Secondary outcome measures
1. Participant-reported resolution of bacterial vaginosis (BV) symptoms (with or without the need for additional treatment) assessed by online questionnaire at 4 weeks
2. Time to participant-reported resolution of BV symptoms without the need for additional treatment assessed by online questionnaire at 4 weeks
3. Microscopic resolution of BV (without the need for additional treatment) on microscopy at 4 weeks as assessed by central laboratory analysis of participant-taken vaginal smears (in a subgroup of participants)
4. Participant reported proportion of prescribed trial BV treatment taken assessed by online questionnaire at 4 weeks
5. Participant-reports of vaginal irritation (itching, pain and/or burning), vaginal discharge, unpleasant vaginal smell, nausea, vomiting, diarrhoea, abdominal pain, unpleasant taste and candida infection assessed by online questionnaire at 4 weeks and 12 weeks
6. Participant-reported acceptability of /satisfaction with treatment assessed by online questionnaire at 4 weeks
7. Participant-reported recurrence of BV symptoms assessed by online questionnaire at 12 weeks
8. Time to participant reported recurrence of BV symptoms assessed by online questionnaire at 12 weeks
9. Cost of BV treatment, including additional medication and healthcare usage relating to BV assessed by online questionnaire at 4 weeks and 12 weeks
Overall trial start date
01/08/2019
Overall trial end date
31/01/2023
Reason abandoned (if study stopped)
Eligibility
Participant inclusion criteria
1. Cisgender women aged 16 years and over
2. Diagnosis of bacterial vaginosis (BV) confirmed by on-site microscopy (Ison-Hay Grade 3) with symptoms of vaginal odour plus or minus vaginal discharge requiring treatment with usual care (BV guideline-recommended) antibiotics
3. Willing to use either intravaginal dequalinium chloride tablets (pessaries) or the clinician selected usual care antibiotic BV treatment
4. Willing to avoid vaginal sex whilst taking/using trial treatment
5. Willing to avoid vaginal douching whilst taking/using trial treatment
6. Willing to complete follow up questionnaires in English
7. Written informed consent to participation given
Participant type
Patient
Age group
Mixed
Gender
Female
Target number of participants
904
Participant exclusion criteria
1. Contra-indications or allergy to dequalinium chloride or clinician selected usual care antibiotic bacterial vaginosis (BV) treatment
2. Concurrent use of oral antibiotics, within the past 14 days or planned use over the next 14 days
3. Concurrent use of intravaginal therapies (including vaginal douching), within the past 14 days or planned use over the next 14 days
4. Diagnosis of any infection at the baseline visit that requires immediate antibiotic treatment
5. Pregnant women who are seeking a termination
6. Pregnant women or women who become pregnant in the first 4 weeks of the trial who are unwilling to provide GP information
7. Previous participation in this trial
Recruitment start date
01/05/2020
Recruitment end date
01/01/2022
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Leeds Teaching Hospital NHS Trust
Genitourinary Medicine
George Street
Leeds
LS1 3EX
United Kingdom
Sponsor information
Organisation
Leeds Teaching Hospitals NHS Trust
Sponsor details
Research and Innovation Centre
Leeds Teaching Hospitals NHS Trust
St James’s University Hospital
Beckett Street
Leeds
LS9 3EX
United Kingdom
+44 01132060454
leedsth-tr.researchgovernance@nhs.net
Sponsor type
Hospital/treatment centre
Website
Funders
Funder type
Government
Funder name
National Institute for Health Research
Alternative name(s)
NIHR
Funding Body Type
government organisation
Funding Body Subtype
National government
Location
United Kingdom
Results and Publications
Publication and dissemination plan
The dissemination of the proposed research findings will be via a published HTA monograph, research papers for publication in peer-reviewed journals, presentation at medical conferences and communication of our findings to groups involved in guideline development.
Results of this trial will be submitted for publication in a peer-reviewed journal.
IPD sharing statement:
The datasets generated during and/or analysed during the current study are/will be available upon request from CTU-admin@nottingham.ac.uk
Updated 26/02/2020:
IPD sharing statement:
The datasets analysed during the current study will be available upon request from the NCTU (ctu@nottingham.ac.uk), a minimum of 6 months after publication of the main results paper. Access to the data will be subject to review of a data sharing and use request by a committee including the CI and sponsor, and will only be granted upon receipt of a data sharing and use agreement. Any data shared will be pseudoanonymised which may impact on the reproducibility of published analyses.
Intention to publish date
30/06/2023
Participant level data
Available on request
Basic results (scientific)
Publication list