drugset / Trial / NCT02120638

Optimization of MDR-TB Treatment Regimen Based on the Molecular Drug Susceptibility Results of Pyrazinamide

NCT02120638

Phase 3 Unknown 100 enrolled Huashan Hospital
Non-randomizedParallel-groupOpen-labelTreatment

Summary

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.

Timeline

Start
2014-04
Primary completion
2016-04
Completion
2016-04

Drugs

EvaluationDrugModalityDoseRoute
Subject Isoniazid Small molecule 600 mg
Comparator Pyrazinamide Small molecule 1000 mg
Comparator Pyrazinamide Small molecule 1750 mg
Comparator Pyrazinamide Small molecule 2000 mg
Comparator Pyrazinamide Small molecule 2500 mg
Comparator Amikacin Small molecule 600 mg
Comparator Clarithromycin Small molecule 500 mg
Comparator Clarithromycin Small molecule 1000 mg
Comparator Levofloxacin Small molecule 750 mg
Comparator Levofloxacin Small molecule 1000 mg
Comparator Protionamide Small molecule 500 mg
Comparator Protionamide Small molecule 750 mg
Comparator Protionamide Small molecule 1000 mg