NCT01215851

Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)

A Phase II Trial to Evaluate the Early Bactericidal Activity, Safety and Tolerability of the Following: TMC207 Alone, TMC207 Plus Pyrazinamide,TMC207 Plus PA-824,PA-824 Plus Pyrazinamide and PA-824 Plus Pyrazinamide and Moxifloxacin, in Adult Patients With Newly Diagnosed, Smear-Positive Pulmonary Tuberculosis.

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 85 (actual)
• Sponsor: Global Alliance for TB Drug Development · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

The trial will evaluate the extended bactericidal activity of 14 consecutive days of oral administration of TMC207 alone, TMC207 with pyrazinamide, TMC207 with PA-824, PA-824 with pyrazinamide and PA-824 with moxifloxacin and pyrazinamide, as determined by the rate of change of log CFU in sputum over the time period Day 0-14 in participants with smear positive pulmonary tuberculosis (TB). A control group will receive standard treatment.

Conditions

• Pulmonary Tuberculosis

Interventions

Type	Name	Description
DRUG	PA-824	200 mg tablet, once daily for 14 days
DRUG	Pyrazinamide	Dosed by Weight
DRUG	TMC207	TMC207 700 mg Day 1; 500mg Day 2; 400mg Days 3-14
DRUG	Rifafour	Rifafour e-275
DRUG	Moxifloxacin	moxifloxacin 400 mg

Timeline

• Start date: 2010-10-01
• Primary completion: 2011-05-01
• Completion: 2011-08-01
• First posted: 2010-10-07
• Last updated: 2017-02-28
• Results posted: 2016-04-01

Locations

2 sites across 1 country: South Africa