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PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis

NCT00567840 ↗

Phase 2 Completed 69 enrolled Global Alliance for TB Drug Development
RandomizedParallel-groupQuadruple-blindTreatment

Summary

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of PA-824 at 200, 600, 1000 and 1200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis. A control group will receive standard TB treatment.

Timeline

Start
2007-08
Primary completion
2007-12
Completion
2007-12

Drugs

EvaluationDrugModalityDoseRoute
Subject Pretomanid Small molecule 200 mg Oral
Subject Pretomanid Small molecule 600 mg Oral
Subject Pretomanid Small molecule 1000 mg Oral
Subject Pretomanid Small molecule 1200 mg Oral

Indications

pulmonary tuberculosis