NCT02619994

Treatment Shortening of MDR-TB Using Existing and New Drugs

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: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 214 (actual)
• Sponsor: Seoul National University Hospital · Academic / Other
• Sex: All
• Age: 19 Years – 85 Years
• Healthy volunteers: Not accepted

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.

Detailed 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).

Conditions

• Tuberculosis, Multidrug-Resistant

Interventions

Type	Name	Description
DRUG	Linezolid
DRUG	Delamanid
DRUG	Levofloxacin
DRUG	Pyrazinamide
DRUG	Locally-used WHO-approved MDR-TB regimen in Korea

Timeline

• Start date: 2016-01-01
• Primary completion: 2021-06-01
• Completion: 2021-06-01
• First posted: 2015-12-02
• Last updated: 2025-01-03
• Results posted: 2025-01-03

Locations

1 site across 1 country: South Korea