Treatment Shortening of MDR-TB Using Existing and New Drugs — MDR-END  

Tuberculosis, Multidrug-Resistant Clinical Trial

Official title: Delamanid, Linezolid, Levofloxacin, and Pyrazinamide for the Treatment of Patients With Fluoroquinolone-sensitive MDR-TB: A Phase 2/3, Multicenter, Randomized, Open-label, Clinical Trial

Status Recruiting

Clinical Trial 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.

Clinical Trial Description

This study is a phase II/III, multicenter, randomized, open-label clinical trial of non-inferiority design comparing a new regimen to the World Health Organization-endorsed conventional regimen for fluoroquinolone-sensitive MDR-TB. The control arm uses a conventional treatment regimen with second-line drugs including injectables for 20-24 months. The investigational arm uses a new shorter regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for 9 or 12 months depending on time to sputum culture conversion. The primary outcome is the treatment success rate at 24 months after treatment initiation. Secondary outcomes include time to sputum culture conversion on liquid and solid media, proportions of sputum culture conversion on liquid media after 2 and 6 months of treatment, treatment success rate according to pyrazinamide resistance, and occurrence of adverse events grade 3 and above as evaluated by the Common Terminology Criteria for Adverse Events. The population number is calculated as 102 per group (204 in total). ;

Related Conditions & MeSH terms

• Tuberculosis
• Tuberculosis, Multidrug-Resistant

• NCT number: NCT02619994
• Study type: Interventional
• Source: Seoul National University Hospital
• Contact: Jae-Joon Yim, MD
• Phone: +82-2-2072-2059
• Email: yimjj@snu.ac.kr
• Status: Recruiting
• Phase: Phase 2
• Start date: January 2016
• Completion date: June 2021