Tuberculosis Clinical Trial
Official title:
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.
n/a
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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