NCT00567840

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

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 69 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: All
• Age: 18 Years – 64 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	PA-824	200 mg, 600 mg, 100 mg, 1200 mg qd

Timeline

• Start date: 2007-08-01
• Primary completion: 2007-12-01
• Completion: 2007-12-01
• First posted: 2007-12-05
• Last updated: 2017-05-15
• Results posted: 2017-04-04

Locations

2 sites across 1 country: South Africa