PA-824-CL-007: Phase IIa Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis
- Registration Number
- NCT00567840
- Lead Sponsor
- Global Alliance for TB Drug Development
- Brief 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 69
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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 1 PA-824 PA-824 200 mg/qd 5 PA-824 Rifafour e-275 mg 4 PA-824 PA-824 1200 mg/qd 2 PA-824 PA-824 600 mg/qd 3 PA-824 PA-824 1000 mg/qd
- Primary Outcome Measures
Name Time Method Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-14). Day 0 and Day 14
- Secondary Outcome Measures
Name Time Method Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 0-2). Day 0 and Day 2 Early Bactericidal Activity (EBA) Measured as the Daily Rate of Change in log10 CFUs (Colony Forming Units) of M. Tuberculosis in Sputum on Solid Media (Days 2-14). Day 2 and Day 14 EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-14) Day 0 and Day 14 EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 0-2) Day 0 and Day 2 EBA Expressed as the Change in Time to Positive (TTP) Signal in Liquid Culture for M. Tuberculosis (Days 2-14) Show Description: [Not Specified] Day 2 and Day 14
Trial Locations
- Locations (2)
Tiervlei Trials Center, Stellenbosch University
🇿🇦Cape Town, Cape Province, South Africa
University of Cape Town Lung Institute
🇿🇦Cape Town, Cape Province, South Africa