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

Bacterial Vaginosis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00313131
• Other study ID #: CHUS 03-32
• Status: Completed
• Phase: Phase 3
• First received: April 7, 2006
• Last updated: April 7, 2006
• Start date: January 2004
• Est. completion date: May 2005

Study information

• Verified date: September 2005
• Source: Université de Sherbrooke
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1524
• Est. completion date: May 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 11 Years and older

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bacterial Vaginosis
• Candidiasis
• Vaginal Discharge
• Vaginitis
• Vaginosis, Bacterial

Intervention

Drug:
• tinidazole+fluconazole vs metronidazole+clotrimazole

Locations

Country	Name	City	State
Ghana	Adabraka Polyclinic	Accra
Ghana	Suntreso Polyclinc	Kumasi
Guinea	Centre de Santé Carrière	Conakry
Guinea	Centre de Santé Madina	Conakry
Togo	Centre de Santé d'Adakpamé	Adakpame
Togo	Clinique IST d'Agoe Nyivé	Lomé
Togo	Clinique IST d'Amoutivé	Lomé

Sponsors (2)

Lead Sponsor	Collaborator
Université de Sherbrooke	Canadian International Development Agency

Countries where clinical trial is conducted

Ghana,  Guinea,  Togo, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Symptomatic resolution of the vaginal discharge according to the patient
Secondary	Objective resolution of the vaginal discharge according to the study nurse or medical officer