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Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00313131
Recruitment Status : Completed
First Posted : April 11, 2006
Last Update Posted : April 11, 2006
Canadian International Development Agency
Information provided by:
Université de Sherbrooke

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

Condition or disease Intervention/treatment Phase
Bacterial Vaginosis Candidiasis Vaginitis Drug: tinidazole+fluconazole vs metronidazole+clotrimazole Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Enrollment : 1524 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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
Study Start Date : January 2004
Study Completion Date : May 2005

Resource links provided by the National Library of Medicine

Primary Outcome Measures :
  1. Symptomatic resolution of the vaginal discharge according to the patient

Secondary Outcome Measures :
  1. Objective resolution of the vaginal discharge according to the study nurse or medical officer

Information from the National Library of Medicine

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Ages Eligible for Study:   11 Years and older   (Child, Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00313131

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Adabraka Polyclinic
Accra, Ghana
Suntreso Polyclinc
Kumasi, Ghana
Centre de Santé Carrière
Conakry, Guinea
Centre de Santé Madina
Conakry, Guinea
Centre de Santé d'Adakpamé
Adakpame, Togo
Clinique IST d'Agoe Nyivé
Lomé, Togo
Clinique IST d'Amoutivé
Lomé, Togo
Sponsors and Collaborators
Université de Sherbrooke
Canadian International Development Agency
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Principal Investigator: Jacques Pepin, MD U of Sherbrooke
Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00313131    
Other Study ID Numbers: CHUS 03-32
First Posted: April 11, 2006    Key Record Dates
Last Update Posted: April 11, 2006
Last Verified: September 2005
Keywords provided by Université de Sherbrooke:
bacterial vaginosis
vaginal candidiasis
Additional relevant MeSH terms:
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Vaginosis, Bacterial
Vaginal Diseases
Vaginal Discharge
Genital Diseases, Female
Bacterial Infections
Anti-Infective Agents
Anti-Bacterial Agents
Antiprotozoal Agents
Antiparasitic Agents
Antifungal Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Cytochrome P-450 CYP2C9 Inhibitors
Cytochrome P-450 CYP2C19 Inhibitors
Anti-Infective Agents, Local
Cytochrome P-450 CYP3A Inhibitors