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

NCT ID: NCT00313131

Last Updated: 2006-04-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1524 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-01-31
• Study Completion Date: 2005-05-31

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.

Conditions

Bacterial Vaginosis; Candidiasis; Vaginitis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

tinidazole+fluconazole vs metronidazole+clotrimazole

Intervention Type: DRUG

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

• Minimum Eligible Age: 11 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Canadian International Development Agency

OTHER_GOV

Sponsor Role: collaborator

Université de Sherbrooke

OTHER

Sponsor Role: lead

Principal Investigators

Jacques Pepin, MD

Role: PRINCIPAL_INVESTIGATOR

U of Sherbrooke

Locations

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

Adakpamé, , Togo

Clinique IST d'Agoe Nyivé

Lomé, , Togo

Clinique IST d'Amoutivé

Lomé, , Togo

Countries

Ghana; Guinea; Togo

References

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.

Reference Type: DERIVED

PMID: 17128343 (View on PubMed)

Other Identifiers

CHUS 03-32

Identifier Type: -

Identifier Source: org_study_id