Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments
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Purpose
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
| Condition | Intervention | Phase |
|---|---|---|
|
Bacterial Vaginosis Candidiasis Vaginitis |
Drug: tinidazole+fluconazole vs metronidazole+clotrimazole |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- Symptomatic resolution of the vaginal discharge according to the patient
- Objective resolution of the vaginal discharge according to the study nurse or medical officer
| Estimated Enrollment: | 1524 |
| Study Start Date: | January 2004 |
| Estimated Study Completion Date: | May 2005 |
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.
Eligibility| Ages Eligible for Study: | 11 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations| Ghana | |
| Adabraka Polyclinic | |
| Accra, Ghana | |
| Suntreso Polyclinc | |
| Kumasi, Ghana | |
| Guinea | |
| Centre de Santé Madina | |
| Conakry, Guinea | |
| Centre de Santé Carrière | |
| Conakry, Guinea | |
| Togo | |
| Centre de Santé d'Adakpamé | |
| Adakpame, Togo | |
| Clinique IST d'Amoutivé | |
| Lomé, Togo | |
| Clinique IST d'Agoe Nyivé | |
| Lomé, Togo | |
| Principal Investigator: | Jacques Pepin, MD | U of Sherbrooke |
More Information
No publications provided by Universitaire de Sherbrooke
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| ClinicalTrials.gov Identifier: | NCT00313131 History of Changes |
| Other Study ID Numbers: | CHUS 03-32 |
| Study First Received: | April 7, 2006 |
| Last Updated: | April 7, 2006 |
| Health Authority: | Canada: Health Canada |
Keywords provided by Universitaire de Sherbrooke:
|
bacterial vaginosis vaginal candidiasis trichomoniasis vaginitis |
Ghana Togo Mali Guinea |
Additional relevant MeSH terms:
|
Vaginal Discharge Vaginal Diseases Genital Diseases, Female Candidiasis Vaginitis Vaginosis, Bacterial Mycoses Bacterial Infections Clotrimazole Miconazole Fluconazole Metronidazole Tinidazole Anti-Infective Agents, Local |
Anti-Infective Agents Therapeutic Uses Pharmacologic Actions 14-alpha Demethylase Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antifungal Agents Radiation-Sensitizing Agents Physiological Effects of Drugs Antiprotozoal Agents Antiparasitic Agents Alkylating Agents Antitrichomonal Agents |
ClinicalTrials.gov processed this record on June 18, 2013