Last reviewed · How we verify
A Phase II Randomized, Open-label Trial of a Rifapentine Plus Moxifloxacin-Based Regimen for Intensive Phase Treatment of Smear-Positive Pulmonary Tuberculosis
Although effective therapy for tuberculosis is available, TB continues to cause significant problems worldwide, and rates of multi-drug resistant (MDR) TB cases are on the rise. A major obstacle to the control of TB is poor adherence with lengthy (usually 6 months) and complicated treatment regimens. Incomplete TB treatment can lead to serious consequences such as increased severity of illness and death, prolonged infectiousness and transmission in the community, and the development of drug resistance. The development of new treatment strategies with more stronger drugs could lead to shorter and simpler regimens. A TB treatment regimen that allowed treatment duration to be meaningfully decreased would have important public health implications. This trial will compare the effect and safety of a new oral regimen to that of the standard regimen for the first phase of treatment for pulmonary tuberculosis. The experimental regimen will consist of the following: * Two months of isoniazid, rifapentine, pyrazinamide and moxifloxacin (HPZM) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid. The standard control intensive phase regimen will consist of the following: * Two months of isoniazid, rifampin, pyrazinamide, and ethambutol (HRZE) administered once daily. Pyridoxine (vitamin B6) will be given with each dose of isoniazid. Following intensive phase therapy (the study phase), all patients will be treated with a non-experimental continuation phase regimen. In mice, the combination of Moxifloxacin and Rifapentine have cured the animals significantly faster than the standard regimen and this study will be the first step to see if the potential is also there in humans.
Details
| Lead sponsor | Johns Hopkins University |
|---|---|
| Phase | Phase 2 |
| Status | TERMINATED |
| Enrolment | 121 |
| Start date | 2009-11 |
| Completion | 2013-04 |
Conditions
- Tuberculosis
Interventions
- Rifapentine, Moxifloxacin, Pyrazinamide, Isoniazid
- Isoniazid, Rifampin, Pyrazinamide, Ethambutol
Primary outcomes
- To Compare, by Treatment Group, the Percentage of Patients With a Negative Sputum Culture at the End of Intensive Phase Therapy. — Week 8
LJ culture conversion - To Compare the Safety and Tolerability of the 2 Intensive Phase Regimens. — Weekly or more frequent
Study was prematurely terminated and data was not collected for this outcome measure.
Countries
Brazil