Multidrug Resistant Tuberculosis Clinical Trial
Official title:
Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide
Multidrug resistant tuberculosis (MDR-TB) is difficult to treat and raises a great challenge to TB control program. That pyrazinamide can shorten the course of treatment and facilitate bacilli clearance has been proved recently. In 2011, WHO recommended to use pyrazinamide throughout the course of treatment for MDR-TB. However, pyrazinamide susceptibility testing has not been widely used in clinic. And the conventional testing is time-consuming and unreliable. In contrast, the detection of pncA and rpsA mutations with molecular methods can provide rapid results of pyrazinamide susceptibility. The purpose of this study is to evaluate the efficacy of the introduce the molecular testing of pyrazinamide susceptibility in optimizing the MDR-TB treatment regimen.
This is a phase 3, open labeled, prospective cohort study to evaluate the molecular testing
of pyrazinamide susceptibility in optimizing the MDR-TB treatment regimen. Approximately 100
participants will be given the molecular detection of pncA and rpsA mutations and divide
into to the pyrazinamide sensitive comparator group and the pyrazinamide resistant group
based on the susceptibility results. For the pyrazinamide sensitive group, the regimen
contains six months of chemotherapy with pyrazinamide, amikacin, levofloxacin, plus
prothionamide, followed by six months of pyrazinamide, levofloxacin, clarithromycin, plus
prothionamide. For the pyrazinamide resistant group, the regimen contains six months of
chemotherapy with isoniazid, amikacin, levofloxacin, plus prothionamide, followed by
eighteen months of isoniazid, levofloxacin, clarithromycin, plus prothionamide.
The participants will be followed up to 24 months after the start of the treatment. The
primary outcome is the sputum culture conversion and the adverse events. Safety evaluations
that will be performed are the routine lab tests, blood glucose, hearing , vital signs, ECG,
reporting of adverse events, physical examinations and X-rays.
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Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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