Study of Daily Rifapentine for Pulmonary Tuberculosis

NCT00814671 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 153

Last updated 2018-02-06

Study results available
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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)

Conditions

Interventions

DRUG

Rifapentine 450

rifapentine 450 mg

DRUG

Rifapentine 600

rifapentine 600 mg

DRUG

Rifampin

rifampin 600 mg

Sponsors & Collaborators

  • University of Cape Town Lung Institute

    collaborator OTHER
  • University of Cape Town

    collaborator OTHER
  • Johns Hopkins University

    lead OTHER

Principal Investigators

  • Susan Dorman, MD · Johns Hopkins University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-04-30
Primary Completion
2013-06-30
Completion
2014-09-30

Countries

  • South Africa

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00814671 on ClinicalTrials.gov