drugset / Trial / NCT01498419

Evaluation of 8 Weeks of Treatment With the Combination of Moxifloxacin, PA-824 and Pyrazinamide in Patients With Drug Sensitive and Multi Drug-Resistant Pulmonary Tuberculosis (TB) (NC-002)

NCT01498419 ↗

Phase 2 Completed 207 enrolled Global Alliance for TB Drug Development
RandomizedParallel-groupOpen-labelTreatment

Summary

The purpose of this study is to assess the mycobactericidal activity of the moxifloxacin plus PA-824 plus pyrazinamide regimen after 8 weeks of treatment.

Timeline

Start
2012-03
Primary completion
2013-04
Completion
2013-07

Outcome

Met primary endpoint

paper the bactericidal activity of MPa200Z (n=54) on days 0-56 (0·155, 95% Bayesian credibility interval 0·133-0·178) was significantly greater than for HRZE PMID 25795076 ↗

Drugs

EvaluationDrugModalityDoseRoute
Subject Moxifloxacin Small molecule 400 mg —
Subject Pretomanid Small molecule 100 mg —
Subject Pretomanid Small molecule 200 mg —
Subject Pyrazinamide Small molecule 1500 mg —
Comparator Rifafour Unknown — Oral