Bacterial VaginosisPhase 3NCT00313131
Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments
A Phase 3 study testing tinidazole+fluconazole vs metronidazole+clotrimazole in people with Bacterial Vaginosis and Candidiasis, run by Université de Sherbrooke at 7 sites in 3 countries.
Trial summary
This randomised controlled trial aimed to verify whether directly observed single dose treatment (with tinidazole+fluconazole) would be as effective as the longer standard treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic management of women presenting with vaginal discharge… Read more about this study
- Who is it for?
- Ages 11 years and older, women only
- Conditions the study is for
- Bacterial Vaginosis, Candidiasis, Vaginitis
- What is being tested?
- tinidazole+fluconazole vs metronidazole+clotrimazole
- How many people
- 1,524 participants
- Where
- 7 sitesin 3 countries
- Study dates
- Jan 2004to May 2005
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 11 years and older
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- women consulting for vaginal discharge
- local resident
- willingness and ability to consent
Who cannot join
- sex worker consulting for active screening
- main complaint of lower abdominal pain
- allergy to one of the study drugs
Trial locations and contacts
7 sites in 3 countries.
7 sites in 3 countries
Togo3 sites
Centre de Santé d'Adakpamé
Adakpamé
Clinique IST d'Agoe Nyivé
Lomé
Clinique IST d'Amoutivé
Lomé
About this study
Official title: A Randomised Controlled Trial of Single Dose Tinidazole+Fluconazole Versus Longer Courses of Metronidazole+Clotrimazole in the Management of West African Women With Vaginal Discharge
This randomised controlled trial aimed to verify whether directly observed single dose treatment (with tinidazole+fluconazole) would be as effective as the longer standard treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic management of women presenting with vaginal discharge in primary health care centers of Ghana, Togo, Guinea and Mali. It was designed as an effectiveness trial, i.e. it was done under conditions typical of routine work in these health centers
Read the detailed description
Abstract Objective: Evaluate whether single-dose treatments are as effective as standard therapy in the syndromic management of vaginal discharge.
Methods: A randomized controlled effectiveness trial comparing single-dose tinidazole plus fluconazole (TF) to seven days of metronidazole plus three days of vaginal clotrimazole (MC) among 1570 women presenting with vaginal discharge in primary health care institutions of Ghana, Togo, Guinea and Mali. Participants were randomly allocated to one of the two treatments by research nurses or physicians using pre-coded envelopes. Effectiveness was assessed by symptomatic response on day 14.
Findings: The two treatment regimens had similar effectiveness: complete resolution was seen in 66% (TF) and 64% (MC) and partial resolution in 33% (TF) and 34% (MC) of participants (p=0.26). Effectiveness was similar among subgroups with vulvovaginal candidiasis, T. vaginalis vaginitis or bacterial vaginosis. The two treatment regimens had a similar effectiveness among HIV-infected (TF: n=76, 71% complete resolution, 28% partial; MC: n=83, 72% complete, 25% partial, p=0.76) and HIV-uninfected women (TF: n=517, 68% complete, 32% partial; MC: n=466, 65% complete, 33% partial, p=0.20). Cervical infections with N. gonorrhoeae, C. trachomatis and M. genitalium were uncommon among women not involved in sex work, were associated with bacterial vaginosis or T. vaginalis vaginitis, and did not alter response to treatment with agents active against vaginal infections. Four fifths of women not relieved by single-dose TF had a favourable response when MC was administered as second-line treatment.
Conclusion: Single-dose TF is as effective as multiple-dose MC in the syndromic management of vaginal discharge, even among the HIV-infected. Given its low price and easier compliance, tinidazole/fluconazole should be considered as a first-line treatment of the vaginal discharge syndrome.
- Conditions
- Bacterial Vaginosis, Candidiasis, Vaginitis
- Being tested
- tinidazole+fluconazole vs metronidazole+clotrimazole
- Keywords
- bacterial vaginosis, vaginal candidiasis, trichomoniasis, vaginitis, Ghana, Togo, Mali, Guinea
- Medical subject headings
- Vaginosis, Bacterial, Candidiasis, Vaginitis, Candidiasis, Vulvovaginal, Trichomonas Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tinidazole+fluconazole vs metronidazole+clotrimazoleDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Symptomatic resolution of the vaginal discharge according to the patient
Secondary outcomes (1)
Objective resolution of the vaginal discharge according to the study nurse or medical officer
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2006 (estimated)
- Study startJan 2004
- Study completionMay 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bacterial VaginosisStudies of the same condition, open and under way.
- More trials run by Université de SherbrookeThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,524 participants
Sponsor and investigators
- Lead sponsor
- Université de Sherbrooke
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian International Development Agency
- Investigators
- Jacques Pepin, MD, Principal investigator, U of Sherbrooke
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00313131
- Sponsor's protocol ID
- CHUS 03-32
- Status last verified
- Sep 2005
- First submitted
- 7 Apr 2006
- Last updated
- 11 Apr 2006
- Results posted
- No
Publications
Pepin J, Sobela F, Khonde N, Agyarko-Poku T, Diakite S, Deslandes S, Labbe AC, Sylla M, Asamoah-Adu C, Frost E. The syndromic management of vaginal discharge using single-dose treatments: a randomized controlled trial in West Africa. Bull World Health Organ. 2006 Sep;84(9):729-38. doi: 10.2471/blt.06.029819.
PubMed 17128343
Study at a glance
From the registry record, last updated by the sponsor on 11 Apr 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Single Dose Tinidazole+Fluconazole Versus Longer Courses of Metronidazole+Clotrimazole in the Management of West African Women With Vaginal Discharge
- ClinicalTrials.gov ID
- NCT00313131
- Acronym / sponsor ID
- CHUS 03-32
- Conditions
- Bacterial Vaginosis, Candidiasis, Vaginitis
- Keywords
- bacterial vaginosis, vaginal candidiasis, trichomoniasis, vaginitis, Ghana, Togo, Mali, Guinea
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,524 participants
- Lead sponsor
- Université de SherbrookeUniversity, hospital or other
- Collaborators
- Canadian International Development Agency
- Study start
- Jan 2004
- Study completion
- May 2005
- First posted
- 11 Apr 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This randomised controlled trial aimed to verify whether directly observed single dose treatment (with tinidazole+fluconazole) would be as effective as the longer standard treatments (metronidazole for 7 days, plus vaginal clotrimazole for 3 days) in the syndromic management of women presenting with vaginal discharge in primary health care centers of Ghana, Togo, Guinea and Mali. It was designed as an effectiveness trial, i.e. it was done under conditions typical of routine work in these health centers
Detailed description
Abstract Objective: Evaluate whether single-dose treatments are as effective as standard therapy in the syndromic management of vaginal discharge.
Methods: A randomized controlled effectiveness trial comparing single-dose tinidazole plus fluconazole (TF) to seven days of metronidazole plus three days of vaginal clotrimazole (MC) among 1570 women presenting with vaginal discharge in primary health care institutions of Ghana, Togo, Guinea and Mali. Participants were randomly allocated to one of the two treatments by research nurses or physicians using pre-coded envelopes. Effectiveness was assessed by symptomatic response on day 14.
Findings: The two treatment regimens had similar effectiveness: complete resolution was seen in 66% (TF) and 64% (MC) and partial resolution in 33% (TF) and 34% (MC) of participants (p=0.26). Effectiveness was similar among subgroups with vulvovaginal candidiasis, T. vaginalis vaginitis or bacterial vaginosis. The two treatment regimens had a similar effectiveness among HIV-infected (TF: n=76, 71% complete resolution, 28% partial; MC: n=83, 72% complete, 25% partial, p=0.76) and HIV-uninfected women (TF: n=517, 68% complete, 32% partial; MC: n=466, 65% complete, 33% partial, p=0.20). Cervical infections with N. gonorrhoeae, C. trachomatis and M. genitalium were uncommon among women not involved in sex work, were associated with bacterial vaginosis or T. vaginalis vaginitis, and did not alter response to treatment with agents active against vaginal infections. Four fifths of women not relieved by single-dose TF had a favourable response when MC was administered as second-line treatment.
Conclusion: Single-dose TF is as effective as multiple-dose MC in the syndromic management of vaginal discharge, even among the HIV-infected. Given its low price and easier compliance, tinidazole/fluconazole should be considered as a first-line treatment of the vaginal discharge syndrome.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 11 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- women consulting for vaginal discharge
- local resident
- willingness and ability to consent
Key exclusion criteria (3 listed)
- sex worker consulting for active screening
- main complaint of lower abdominal pain
- allergy to one of the study drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tinidazole+fluconazole vs metronidazole+clotrimazole | Drug | – |
Primary outcome
Symptomatic resolution of the vaginal discharge according to the patient
1 secondary outcome
Objective resolution of the vaginal discharge according to the study nurse or medical officer
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Apr 2006.
- Derived from this study: PubMed 17128343Pepin J, Sobela F, Khonde N, Agyarko-Poku T, Diakite S, Deslandes S, Labbe AC, Sylla M, Asamoah-Adu C, Frost E. The syndromic management of vaginal discharge using single-dose treatments: a randomized controlled trial in West Africa. Bull World Health Organ. 2006 Sep;84(9):729-38. doi: 10.2471/blt.06.029819.
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Enrolling by invitationObservational study
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WST03 Capsule Combined With Metronidazole for Bacterial Vaginosis
Bacterial Vaginosis (BV)
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A Randomized, Multicenter, Open-label, Active-controlled Phase Ib Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of Multiple Intravaginal Doses of GenSci142 in Patients With Bacterial Vaginosis (BV)
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Recruiting
Multi-Gyn ActiGel Plus for Treatment of Bacterial Vaginosis
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jacques Pepin, MD principal investigator
U of Sherbrooke
7 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing tinidazole+fluconazole vs metronidazole+clotrimazole in people with Bacterial Vaginosis and Candidiasis, run by Université de Sherbrooke at 7 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Apr 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Togo, Ghana, Guinea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Symptomatic resolution of the vaginal discharge according to the patient. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00313131, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2006.