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

• Status: Completed
• Trial end date: 2007-12-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Global Alliance for TB Drug Development

Criteria

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