CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 157 enrolled
Drug / intervention
PA-824 +5 moredrug
Likely dose
PA-824 200 mgfrom 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.

Search/NCT02256696
NCT02256696Phase 2Completed
CompareCT.gov

A Phase 2 Randomized, Open-Label Trial of PA-824-Containing Regimens Versus Standard Treatment for Drug-Sensitive Sputum Smear-Positive Pulmonary Tuberculosis

Johns Hopkins University·interventional·Posted Oct 6, 2014·Updated Jul 18, 2023

In Brief

A Phase 2 clinical trial evaluating PA-824, Rifampin, and 4 other interventions for Pulmonary Tuberculosis. Completed, enrolled 157 participants across 1 site.

Detailed Summary

Assess the mycobactericidal activity of PA-824 (given at 200 mg daily) when added to first-line tuberculosis (TB) treatment (isoniazid, pyrazinamide, and a rifamycin antibiotic) over 12 weeks of treatment. Funding Source - FDA Office of Orphan Products Development (OOPD)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPulmonary Tuberculosis
CountriesSouth Africa
CollaboratorsUniversity of Cape Town

Timeline

Phase 2CompletedFinished
201520162017201820192020202120222023202420252026
First PostedOct 6, 2014
Enrollment StartApr 29, 2015
Primary CompletionMay 1, 2022
TodayJul 2, 2026
Enrollment to primary: 7.0 yearsPosted 11.7 years ago

Interventions

PA-824drug

200 mg QD

Rifampindrug

600 mg QD

Rifabutindrug

300 mg QD

Pyrazinamidedrug

25mg/kg QD

Ethambutoldrug

15mg/kg QD

Isoniaziddrug

300 mg QD