Tuberculosis, Pulmonary, Drug Sensitive Clinical Trial
Official title:
A Phase 3 Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin Plus PA-824 Plus Pyrazinamide After 4 and 6 Months of Treatment in Adult Subjects With Drug-Sensitive Smear-Positive Pulmonary Tuberculosis and After 6 Months of Treatment in Adult Subjects With Multi-Drug Resistant, Smear-Positive Pulmonary Tuberculosis.
The purpose of this study is to assess the efficacy, safety and tolerability of a combination
of moxifloxacin, PA-824, and pyrazinamide treatments with varying doses and treatment lengths
from 4 to 6 months in subjects with drug-sensitive (DS) pulmonary TB compared to standard
HRZE treatment.
This study will also assess the efficacy, safety and tolerability of a combination of
moxifloxacin, PA-824, and pyrazinamide treatments after 6 months of treatment in subjects
with multi drug-resistant (MDR) pulmonary TB compared to a combination of moxifloxacin,
PA-824, and pyrazinamide treatments in DS-TB subjects.
n/a