CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 214 enrolled
Drug / intervention
Linezolid +4 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02619994
NCT02619994Phase 2Completed
CompareCT.gov

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

Seoul National University Hospital·interventional·Posted Dec 2, 2015·Updated Jan 3, 2025

In Brief

A Phase 2 clinical trial evaluating Linezolid, Delamanid, and 3 other interventions for Tuberculosis, Multidrug-Resistant. Completed, enrolled 214 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTuberculosis, Multidrug-Resistant
CountriesSouth Korea
CollaboratorsAsan Medical Center, Dankook University, International Tuberculosis Research Center, Pusan National University Yangsan Hospital, Pusan National University Hospital, Samsung Medical Center, Severance Hospital, SMG-SNU Boramae Medical Center, Incheon St.Mary's Hospital, Ulsan University Hospital, Korean Institute of Tuberculosis, National Medical Center, Seoul, Korean Center for Disease Control and Prevention, Korea University Ansan Hospital

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedDec 2, 2015
Enrollment StartJan 1, 2016
Primary CompletionJun 1, 2021
TodayJul 2, 2026
Enrollment to primary: 5.4 yearsPosted 10.6 years ago

Interventions

Linezoliddrug

Delamaniddrug

Levofloxacindrug

Pyrazinamidedrug

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