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

NCT02120638 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2014-04-23

No results posted yet for this study

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.

Conditions

  • Multidrug Resistant Tuberculosis

Interventions

DRUG

Pyrazinamide containing regimen

Pyrazinamide 33-50kg 1000-1750 mg daily, 51-70kg 1750-2000 daily, \>70kg 2000-2500mg daily Amikacin 600mg daily Levofloxacin 33-70kg 750 mg daily, \>70kg 1000 mg daily Clarithromycin 33-50kg 500 mg daily, \>50kg 1000 mg daily Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, \>70kg 1000 mg daily All treatment is taken daily, for a duration of up to 12 months depending on treatment arm.

DRUG

Regimen without Pyrazinamide

Isoniazid 600mg daily Amikacin 600mg daily Levofloxacin 33-70kg 750 mg daily, \>70kg 1000 mg daily Clarithromycin 33-50kg 500 mg daily, \>50kg 1000 mg daily Prothionamide 33-50kg 500 mg daily, 51-70kg 750 daily, \>70kg 1000 mg daily All treatment is taken daily, for a duration of up to 18 months depending on treatment arm.

Sponsors & Collaborators

  • Huashan Hospital

    lead OTHER

Principal Investigators

  • Ying Zhang, PhD · Huashan Hospital of Fudan University, Shanghai, China;Johns Hopkins University, Baltimore, Maryland, USA

  • Wenhong Zhang, PhD,MD · Huashan Hospital of Fudan University, Shanghai, China

Study Design

Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-04-30
Primary Completion
2016-04-30
Completion
2016-04-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02120638 on ClinicalTrials.gov