CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 153 enrolled
Drug / intervention
Rifapentine 450 +2 moredrug
Likely dose
Rifapentine 450 450 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/NCT00814671
NCT00814671Phase 2Completed
CompareCT.gov

A Phase 2 Randomized, Open-label Trial of Daily Rifapentine 450mg or 600mg in Place of Rifampicin 600mg for Intensive Phase Treatment of Smear-positive Pulmonary Tuberculosis

Johns Hopkins University·interventional·Posted Dec 25, 2008·Updated Feb 6, 2018

In Brief

A Phase 2 clinical trial evaluating Rifapentine 450, Rifapentine 600, and 1 other intervention for Tuberculosis. Completed, enrolled 153 participants across 1 site.

Detailed Summary

The goal of this Phase 2 study is to determine the microbiological activity and safety of rifapentine when given as a component of multidrug intensive phase treatment of smear-positive pulmonary tuberculosis (TB). Funding Source- FDA Office of Orphan Products Development (OOPD)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis
CountriesSouth Africa
CollaboratorsUniversity of Cape Town Lung Institute, University of Cape Town

Timeline

Phase 2CompletedFinished
200920102011201220132014201520162017201820192020202120222023202420252026
First PostedDec 25, 2008
Enrollment StartApr 1, 2010
Primary CompletionJun 1, 2013
Study CompletionSep 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.2 yearsPosted 17.5 years ago

Interventions

Rifapentine 450drug

rifapentine 450 mg

Rifapentine 600drug

rifapentine 600 mg

Rifampindrug

rifampin 600 mg