Clinical trial NCT00313131: Study of the Management of Vaginal Discharge in West African Using Single Dose Treatments
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bacterial Vaginosis
Candidiasis
Vaginitis
Keywords: bacterial vaginosis
vaginal candidiasis
trichomoniasis
vaginitis
Ghana
Togo
Mali
Guinea
Lead sponsor: Université de Sherbrooke
Sponsor class: OTHER
Collaborators: name: Canadian International Development Agency
First posted: 2006-04-11
Enrollment: 1524
Sex: FEMALE
Minimum age (years): 11
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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

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 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

Primary outcomes:
measure: Symptomatic resolution of the vaginal discharge according to the patient
Secondary outcomes:
measure: Objective resolution of the vaginal discharge according to the study nurse or medical officer
Other outcomes:
Locations:
city: Accra
country: Ghana
facility: Adabraka Polyclinic
city: Kumasi
country: Ghana
facility: Suntreso Polyclinc
city: Conakry
country: Guinea
facility: Centre de Santé Carrière
city: Conakry
country: Guinea
facility: Centre de Santé Madina
city: Adakpame
country: Togo
facility: Centre de Santé d'Adakpamé
city: Lomé
country: Togo
facility: Clinique IST d'Agoe Nyivé
city: Lomé
country: Togo
facility: Clinique IST d'Amoutivé
Study officials:
affiliation: U of Sherbrooke
name: Jacques Pepin, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Pepin J, Sobela F, Khonde N, Agyarko-Poku T, Diakite S, Deslandes S, Labbe AC, Sylla M, Asamoah-Adu C, Frost E. The syndromic management of vaginal discharge using single-dose treatments: a randomized controlled trial in West Africa. Bull World Health Organ. 2006 Sep;84(9):729-38. doi: 10.2471/blt.06.029819.