Status:
UNKNOWN
Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis
Lead Sponsor:
International Union Against Tuberculosis and Lung Diseases
Collaborating Sponsors:
United States Agency for International Development (USAID)
Conditions:
Tuberculosis
Eligibility:
All Genders
18-65 years
Phase:
PHASE4
Brief Summary
The use of fixed-dose combined (FDC) drugs in the treatment of tuberculosis by National Tuberculosis Programmes has been recommended by both the International Union Against Tuberculosis and Lung Disea...
Detailed Description
This is a multiple country, multicenter study, using the parallel group open-label randomised trial design. The primary objective of this investigation is to assess the efficacy, acceptability and tox...
Eligibility Criteria
Inclusion
- Patients with newly diagnosed pulmonary tuberculosis
- two sputum specimens positive for acid-fast bacilli on direct smear microscopy
- no previous anti-tuberculosis chemotherapy
- aged 18 years and over
- firm home address that is readily accessible for visiting for the duration of the trial (including follow up period)
- agree to participate in the study and to give a sample of blood for HIV test
Exclusion
- patients in a moribund state,
- TB meningitis,
- pre-existing diseases: insulin-dependent diabetes, liver or kidney disease, blood disorders, peripheral neuritis,
- pregnancy or breast feeding,
- psychiatric illness
- alcoholism
- contraindication to any medications in the study regimens
Key Trial Info
Start Date :
December 1 2003
Trial Type :
INTERVENTIONAL
End Date :
June 1 2007
Estimated Enrollment :
1500 Patients enrolled
Trial Details
Trial ID
NCT00216333
Start Date
December 1 2003
End Date
June 1 2007
Last Update
September 13 2006
Active Locations (9)
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1
Service de Pneumo-phtisiologie de Matiben
Algiers, Algeria
2
Program Nal. de Control de la Tuberculosis
Santa Cruz, Bolivia
3
Centro Internacional de Entrenamiento
Cali, Colombia
4
CHU Ignace Deen
Conakry, Guinea