Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments
Primary Purpose
Bacterial Vaginosis, Candidiasis, Vaginitis
Status
Completed
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
tinidazole+fluconazole vs metronidazole+clotrimazole
Sponsored by
About this trial
This is an interventional treatment trial for Bacterial Vaginosis focused on measuring bacterial vaginosis, vaginal candidiasis, trichomoniasis, vaginitis, Ghana, Togo, Mali, Guinea
Eligibility Criteria
Inclusion Criteria: women consulting for vaginal discharge local resident willingness and ability to consent Exclusion Criteria: sex worker consulting for active screening main complaint of lower abdominal pain allergy to one of the study drugs
Sites / Locations
- Adabraka Polyclinic
- Suntreso Polyclinc
- Centre de Santé Carrière
- Centre de Santé Madina
- Centre de Santé d'Adakpamé
- Clinique IST d'Agoe Nyivé
- Clinique IST d'Amoutivé
Outcomes
Primary Outcome Measures
Symptomatic resolution of the vaginal discharge according to the patient
Secondary Outcome Measures
Objective resolution of the vaginal discharge according to the study nurse or medical officer
Full Information
NCT ID
NCT00313131
First Posted
April 7, 2006
Last Updated
April 7, 2006
Sponsor
Université de Sherbrooke
Collaborators
Canadian International Development Agency
1. Study Identification
Unique Protocol Identification Number
NCT00313131
Brief Title
Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments
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
Study Type
Interventional
2. Study Status
Record Verification Date
September 2005
Overall Recruitment Status
Completed
Study Start Date
January 2004 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
May 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
Université de Sherbrooke
Collaborators
Canadian International Development Agency
4. Oversight
5. Study Description
Brief 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 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Bacterial Vaginosis, Candidiasis, Vaginitis
Keywords
bacterial vaginosis, vaginal candidiasis, trichomoniasis, vaginitis, Ghana, Togo, Mali, Guinea
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1524 (false)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
tinidazole+fluconazole vs metronidazole+clotrimazole
Primary Outcome Measure Information:
Title
Symptomatic resolution of the vaginal discharge according to the patient
Secondary Outcome Measure Information:
Title
Objective resolution of the vaginal discharge according to the study nurse or medical officer
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
11 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
women consulting for vaginal discharge
local resident
willingness and ability to consent
Exclusion Criteria:
sex worker consulting for active screening
main complaint of lower abdominal pain
allergy to one of the study drugs
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jacques Pepin, MD
Organizational Affiliation
U of Sherbrooke
Official's Role
Principal Investigator
Facility Information:
Facility Name
Adabraka Polyclinic
City
Accra
Country
Ghana
Facility Name
Suntreso Polyclinc
City
Kumasi
Country
Ghana
Facility Name
Centre de Santé Carrière
City
Conakry
Country
Guinea
Facility Name
Centre de Santé Madina
City
Conakry
Country
Guinea
Facility Name
Centre de Santé d'Adakpamé
City
Adakpame
Country
Togo
Facility Name
Clinique IST d'Agoe Nyivé
City
Lomé
Country
Togo
Facility Name
Clinique IST d'Amoutivé
City
Lomé
Country
Togo
12. IPD Sharing Statement
Citations:
PubMed Identifier
17128343
Citation
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.
Results Reference
derived
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Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments
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