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

Condition(s) targeted: Bacterial Vaginosis; Candidiasis; Vaginitis

Intervention: tinidazole+fluconazole vs metronidazole+clotrimazole (Drug)

Phase: Phase 3

Status: Completed

Sponsored by: Universitaire de Sherbrooke

Official(s) and/or principal investigator(s):
Jacques Pepin, MD, Principal Investigator, Affiliation: U of Sherbrooke

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

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 design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Efficacy Study

Primary outcome: Symptomatic resolution of the vaginal discharge according to the patient

Secondary outcome: Objective resolution of the vaginal discharge according to the study nurse or medical officer

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.

Minimum age: 11 Years. Maximum age: N/A. Gender(s): Female.

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

Adabraka Polyclinic, Accra, Ghana

Suntreso Polyclinc, Kumasi, Ghana

Centre de Santé Madina, Conakry, Guinea

Centre de Santé Carrière, Conakry, Guinea

Clinique IST d'Amoutivé, Lomé, Togo

Clinique IST d'Agoe Nyivé, Lomé, Togo

Centre de Santé d'Adakpamé, Adakpame, Togo

Starting date: January 2004
Ending date: May 2005
Last updated: April 7, 2006