Evaluation of Early Bactericidal Activity in Pulmonary Tuberculosis With(J-M-Pa-Z) (NC-001)
Status:
Completed
Trial end date:
2011-08-01
Target enrollment:
Participant gender:
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.
Phase:
Phase 2
Details
Lead Sponsor:
Global Alliance for TB Drug Development
Treatments:
Bedaquiline Diarylquinolines Fluoroquinolones Moxifloxacin Norgestimate, ethinyl estradiol drug combination Pyrazinamide