Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis

Status Completed

Clinical Trial Summary

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 at multiple doses as determined by the rate of change of logCFU in sputum over the time period Day 7-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

Clinical Trial Description

n/a

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT01215110
Study type	Interventional
Source	Global Alliance for TB Drug Development
Contact
Status	Completed
Phase	Phase 2
Start date	April 2010
Completion date	August 2010

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