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drugset / Trial / NCT01215851

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

NCT01215851 ↗

Phase 2 Completed 85 enrolled Global Alliance for TB Drug Development
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2010-10
Primary completion
2011-05
Completion
2011-08

Publications

Drugs

EvaluationDrugModalityDoseRoute
Subject Bedaquiline Small molecule 400 mg Oral
Comparator Ethambutol Small molecule 550 mg —
Comparator Ethambutol Small molecule 825 mg —
Comparator Ethambutol Small molecule 1100 mg —
Comparator Ethambutol Small molecule 1375 mg —
Comparator Isoniazid Small molecule 150 mg —
Comparator Isoniazid Small molecule 225 mg —
Comparator Isoniazid Small molecule 300 mg —
Comparator Isoniazid Small molecule 375 mg —
Subject Moxifloxacin Small molecule 400 mg Oral
Subject Pretomanid Small molecule 200 mg Oral
Comparator Pyrazinamide Small molecule 800 mg —
Comparator Pyrazinamide Small molecule 1000 mg Oral
Comparator Pyrazinamide Small molecule 1200 mg —
Comparator Pyrazinamide Small molecule 1500 mg Oral
Comparator Pyrazinamide Small molecule 1600 mg —
Comparator Pyrazinamide Small molecule 2000 mg Oral
Comparator Pyrazinamide Small molecule 2000 mg —
Comparator Rifampin Small molecule 300 mg —
Comparator Rifampin Small molecule 450 mg —
Comparator Rifampin Small molecule 600 mg —
Comparator Rifampin Small molecule 750 mg —

Indications

pulmonary tuberculosis