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Sponsors and Collaborators: |
Universitaire de Sherbrooke Canadian International Development Agency |
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Information provided by: | Universitaire de Sherbrooke |
ClinicalTrials.gov Identifier: | NCT00313131 |
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 III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy 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 |
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.
Ages Eligible for Study: | 11 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Ghana | |
Adabraka Polyclinic | |
Accra, Ghana | |
Suntreso Polyclinc | |
Kumasi, Ghana | |
Guinea | |
Centre de Santé Madina | |
Conakry, Guinea | |
Centre de Santé Carrière | |
Conakry, Guinea | |
Togo | |
Clinique IST d'Amoutivé | |
Lomé, Togo | |
Clinique IST d'Agoe Nyivé | |
Lomé, Togo | |
Centre de Santé d'Adakpamé | |
Adakpame, Togo |
Principal Investigator: | Jacques Pepin, MD | U of Sherbrooke |
Study ID Numbers: | CHUS 03-32 |
Study First Received: | April 7, 2006 |
Last Updated: | April 7, 2006 |
ClinicalTrials.gov Identifier: | NCT00313131 History of Changes |
Health Authority: | Canada: Health Canada |
bacterial vaginosis vaginal candidiasis trichomoniasis vaginitis |
Ghana Togo Mali Guinea |
Fluconazole Bacterial Infections Metronidazole Candidiasis Vaginal Discharge Clotrimazole Miconazole Vaginitis Tioconazole Trichomonas Infections |
Vaginal Diseases Genital Diseases, Female Anti-Infective Agents, Local Mycoses Vaginosis, Bacterial Radiation-Sensitizing Agents Antifungal Agents Alkylating Agents Tinidazole |
Bacterial Infections Metronidazole Anti-Infective Agents Antiprotozoal Agents Molecular Mechanisms of Pharmacological Action Vaginal Discharge Candidiasis Clotrimazole Miconazole Vaginitis Physiological Effects of Drugs Vaginal Diseases Genital Diseases, Female |
Mycoses Antiparasitic Agents Vaginosis, Bacterial Antifungal Agents Therapeutic Uses Antitrichomonal Agents Alkylating Agents Tinidazole Fluconazole Tioconazole Pharmacologic Actions Anti-Infective Agents, Local Radiation-Sensitizing Agents |