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

This study has been completed.
Sponsor:
Collaborator:
Canadian International Development Agency
Information provided by:
Université de Sherbrooke
ClinicalTrials.gov Identifier:
NCT00313131
First received: April 7, 2006
Last updated: NA
Last verified: September 2005
History: No changes posted
  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

Resource links provided by NLM:


Further study details as provided by Université de Sherbrooke:

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

Estimated Enrollment: 1524
Study Start Date: January 2004
Estimated Study Completion Date: May 2005
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.

  Eligibility

Ages Eligible for Study:   11 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00313131

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
Sponsors and Collaborators
Université de Sherbrooke
Canadian International Development Agency
Investigators
Principal Investigator: Jacques Pepin, MD U of Sherbrooke
  More Information

No publications provided by Université 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 Université de Sherbrooke:
bacterial vaginosis
vaginal candidiasis
trichomoniasis
vaginitis
Ghana
Togo
Mali
Guinea

Additional relevant MeSH terms:
Vaginitis
Candidiasis
Vaginosis, Bacterial
Vaginal Discharge
Mycoses
Vaginal Diseases
Genital Diseases, Female
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 July 26, 2014