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

A Phase IIa Trial to Evaluate the Safety, Tolerability, Extended Early Bactericidal Activity and Pharmacokinetics of 14 Days' Treatment With Four Oral Doses of PA-824 in Adult Participants With Newly Diagnosed, Uncomplicated, Smear-Positive, Pulmonary Tuberculosis

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.

Inclusion Criteria:

• informed consent
• M/F 18-64 yo
• newly diagnosed pulmonary TB
• sputum positive
• adequate contraception

Exclusion Criteria:

• poor health
• rifampicin resistance
• treatment with other anti TB agents in last 3 mos.
• extrapulmonary TB
• COPD
• neuropathy
• ECG wih QRS prolongation ove 120 msec
• CV disorder
• diabetes requiring insulin
• Metabolic disease
• drug/alcohol abuse
• pregnancy
• use of substances that are strong inhibitors/inducers of CYP450
• use of ARV