Multicenter Trial for the Evaluation of a Fixed Dose Combined Tablet for the Treatment of Pulmonary Tuberculosis
Status:
Unknown status
Trial end date:
2007-06-01
Target enrollment:
Participant gender:
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 Disease (The Union) and the World Health Organisation. The advantages
of FDC drugs include preventing the emergence of drug resistance due to monotherapy, reducing
the risk of incorrect dosage, simplifying procurement and prescribing practices, aiding
adherence and facilitating directly observed treatment. Recent bioavailability studies of
four-drug FDC tablets have demonstrated satisfactory results. In this study, we are testing
the efficacy of this compound, when given in the initial intensive phase of treatment of
patients with newly diagnosed smear positive pulmonary tuberculosis. This will be followed by
four months treatment with a two-drug FDC of rifampicin and isoniazid.
Phase:
Phase 4
Details
Lead Sponsor:
International Union Against Tuberculosis and Lung Diseases
Collaborator:
United States Agency for International Development (USAID)