NCT00944021

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis (CL-010)

A Phase II Dose Ranging Trial to Evaluate the Extended Early Bactericidal Activity, Safety, Tolerability, and Pharmacokinetics 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 50, 100, 150 and 200 mg per day in adult patients with newly diagnosed, uncomplicated, smear positive tuberculosis (TB). A control group will receive standard TB treatment.

Detailed description

The planned sample size of 15 participants per treatment group is in keeping with other Phase II trials of this type and accounts for the possibility of up to 3 drop-outs per arm, which based on previous studies of this type conducted at these sites, represents a conservative estimate of the expected drop-out rate.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	PA-824	50mg
DRUG	PA-824	100mg
DRUG	PA-824	150 mg
DRUG	Rifafour e-275 mg	275 mg
DRUG	PA-824	200 mg

Timeline

• Start date: 2009-08-01
• Primary completion: 2010-01-01
• Completion: 2010-05-01
• First posted: 2009-07-22
• Last updated: 2019-09-20
• Results posted: 2016-03-09