Condition category
Urological and Genital Diseases
Date applied
09/01/2020
Date assigned
20/01/2020
Last edited
20/01/2020
Prospective/Retrospective
Prospectively registered
Overall trial status
Ongoing
Recruitment status
Not yet recruiting

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

www.devastudy.ac.uk

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

http://www.leedsth.nhs.uk/home/

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

Intention to publish date

30/06/2023

Participant level data

Available on request

Basic results (scientific)

Publication list

Publication citations

Additional files

Editorial Notes

10/01/2020: Trial’s existence confirmed by the National Institute for Health Research.