Treatment Shortening of MDR-TB Using Existing and New Drugs

Summary

The purpose of this study is to compare the efficacy of a 'new treatment regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for nine or twelve months (investigational arm)' and 'the standard treatment regimen including injectables for 20 to 24 months (control arm)' for treating fluoroquinolone-sensitive multidrug-resistant tuberculosis.

Conditions

• Tuberculosis, Multidrug-Resistant

Interventions

DRUG

Linezolid

DRUG

Delamanid

DRUG

Levofloxacin

DRUG

Pyrazinamide

DRUG

Locally-used WHO-approved MDR-TB regimen in Korea

Sponsors & Collaborators

• Asan Medical Center

  collaborator OTHER

• Dankook University

  collaborator OTHER

• International Tuberculosis Research Center

  collaborator OTHER

• Pusan National University Yangsan Hospital

  collaborator OTHER

• Pusan National University Hospital

  collaborator OTHER

• Samsung Medical Center

  collaborator OTHER

• Severance Hospital

  collaborator OTHER

• SMG-SNU Boramae Medical Center

  collaborator OTHER

• Incheon St.Mary's Hospital

  collaborator OTHER

• Ulsan University Hospital

  collaborator OTHER

• Korean Institute of Tuberculosis

  collaborator OTHER

• National Medical Center, Seoul

  collaborator OTHER

• Korean Center for Disease Control and Prevention

  collaborator OTHER_GOV

• Korea University Ansan Hospital

  collaborator OTHER

• Seoul National University Hospital

  lead OTHER

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

19 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2016-01-31

Primary Completion

2021-06-30

Completion

2021-06-30

Countries

• South Korea

Study Locations