NCT00313131

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

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,524

participants targeted

Target at P75+ for phase_3

Timeline
Completed

Started Jan 2004

Shorter than P25 for phase_3

Geographic Reach
3 countries

7 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2005

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

April 7, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

April 11, 2006

Completed
Last Updated

April 11, 2006

Status Verified

September 1, 2005

First QC Date

April 7, 2006

Last Update Submit

April 7, 2006

Conditions

Bacterial VaginosisCandidiasisVaginitis

Keywords

bacterial vaginosisvaginal candidiasistrichomoniasisvaginitisGhanaTogoMaliGuinea

Outcome Measures

Primary Outcomes (1)

  • Symptomatic resolution of the vaginal discharge according to the patient

Secondary Outcomes (1)

  • Objective resolution of the vaginal discharge according to the study nurse or medical officer

Interventions

tinidazole+fluconazole vs metronidazole+clotrimazoleDRUG

Eligibility Criteria

Age11 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • women consulting for vaginal discharge
  • local resident
  • willingness and ability to consent

You may not qualify if:

  • sex worker consulting for active screening
  • main complaint of lower abdominal pain
  • allergy to one of the study drugs

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (7)

Adabraka Polyclinic

Accra, Ghana

Location

Suntreso Polyclinc

Kumasi, Ghana

Location

Centre de Santé Carrière

Conakry, Guinea

Location

Centre de Santé Madina

Conakry, Guinea

Location

Centre de Santé d'Adakpamé

Adakpamé, Togo

Location

Clinique IST d'Agoe Nyivé

Lomé, Togo

Location

Clinique IST d'Amoutivé

Lomé, Togo

Location

Related Publications (1)

  • 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.

    PMID: 17128343DERIVED

MeSH Terms

Conditions

Vaginosis, BacterialCandidiasisVaginitisCandidiasis, VulvovaginalTrichomonas Infections

Condition Hierarchy (Ancestors)

Bacterial InfectionsBacterial Infections and MycosesInfectionsVaginal DiseasesGenital Diseases, FemaleFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesGenital DiseasesMycosesVulvovaginitisVulvitisVulvar DiseasesProtozoan InfectionsParasitic Diseases

Study Officials

  • Jacques Pepin, MD

    U of Sherbrooke

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

April 7, 2006

First Posted

April 11, 2006

Study Start

January 1, 2004

Study Completion

May 1, 2005

Last Updated

April 11, 2006

Record last verified: 2005-09

Locations

GH(2)TO(3)GU(2)