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 (MDR-END)

NCT02619994 Phase 2 COMPLETED Results posted

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.

Details

Lead sponsor	Seoul National University Hospital
Phase	Phase 2
Status	COMPLETED
Enrolment	214
Start date	2016-01
Completion	2021-06

Conditions

• Tuberculosis, Multidrug-Resistant

Interventions

• Linezolid
• Delamanid
• Levofloxacin
• Pyrazinamide
• Locally-used WHO-approved MDR-TB regimen in Korea

Primary outcomes

• Treatment Success Rate — 24 months after treatment start
  To test for non-inferiority of the investigational arm, when the lower limit of the one-sided 97.5% confidence interval of the difference (PT - PC) between investigational and control arms is larger than the non-inferiority margin of - 10%, it will be concluded that the treatment success rate of the investigational arm shows non-inferiority to the treatment success rate of the control arm. (primary consideration for the modified intention-to-treat results)

Countries

South Korea