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Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)

Pulmonary Tuberculosis Clinical Trial

Official title:
A Phase II Dose Ranging Trial to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics of PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis

Clinical Trial Summary

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.

Clinical Trial Description

The planned sample size of 15 participants per treatment group is in keeping with other Phase II trials of this type and accounts for the possibility of up to 3 drop-outs per arm, which based on previous studies of this type conducted at these sites, represents a conservative estimate of the expected drop-out rate. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT00944021
Study type Interventional
Source Global Alliance for TB Drug Development
Contact
Status Completed
Phase Phase 2
Start date August 2009
Completion date May 2010
View Details
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