drugset / Trial / NCT00814671
Study of Daily Rifapentine for Pulmonary Tuberculosis
Phase 2
Completed
153 enrolled
Johns Hopkins University
University of Cape Town · collabUniversity of Cape Town Lung Institute · collab
RandomizedParallel-groupOpen-labelTreatment
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)
Timeline
- Start
- 2010-04
- Primary completion
- 2013-06
- Completion
- 2014-09
Publications
- Results Rosenthal IM, Williams K, Tyagi S, Peloquin CA, Vernon AA, Bishai WR, Grosset JH, Nuermberger EL. Potent twice-weekly rifapentine-containing regimens in murine tuberculosis. Am J Respir Crit Care Med. 2006 Jul 1;174(1):94-101. doi: 10.1164/rccm.200602-280OC. Epub 2006 Mar 30.
- Results Rosenthal IM, Williams K, Tyagi S, Vernon AA, Peloquin CA, Bishai WR, Grosset JH, Nuermberger EL. Weekly moxifloxacin and rifapentine is more active than the denver regimen in murine tuberculosis. Am J Respir Crit Care Med. 2005 Dec 1;172(11):1457-62. doi: 10.1164/rccm.200507-1072OC. Epub 2005 Sep 1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | Rifampin | Small molecule | 600 mg | — |
| Subject | Rifapentine | Small molecule | 450 mg | — |
| Subject | Rifapentine | Small molecule | 600 mg | — |