At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 207 enrolled
Drug / intervention
Moxifloxacin (M) +3 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II Open-Label Partially Randomized Trial to Evaluate the Efficacy, Safety and Tolerability of the Combination of Moxifloxacin Plus PA-824 Plus Pyrazinamide After 8 Weeks of Treatment in Adult Patients With Newly Diagnosed Drug-Sensitive or Multi Drug-Resistant, Smear-Positive Pulmonary Tuberculosis
In Brief
A Phase 2 clinical trial evaluating Moxifloxacin (M), Pretomid (Pa), and 2 other interventions for Pulmonary Tuberculosis. Completed, enrolled 207 participants across 8 sites in 2 countries.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Tuberculosis
CountriesSouth Africa, Tanzania
Collaborators--
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedDec 2011
Enrollment StartMar 2012
Primary CompletionApr 2013
Study CompletionJul 2013
TodayJul 2026
First PostedDec 23, 2011
Enrollment StartMar 1, 2012
Primary CompletionApr 1, 2013
Study CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.1 yearsPosted 14.5 years ago
Interventions
Moxifloxacin (M)drug
Pretomid (Pa)drug
Pyrazinamide (Z)drug
Rifafourdrug
Rifafour e-275 once daily for 8 weeks. Daily dose dependent on weight as follows: 30-37kg: 2 tablets, 38-54 kg: 3 tablets, 55-70 kg: 4 tablets: 71 kg and over: 5 tablets