Treatment Shortening of MDR-TB Using Existing and New Drugs (MDR-END)
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|ClinicalTrials.gov Identifier: NCT02619994|
Recruitment Status : Recruiting
First Posted : December 2, 2015
Last Update Posted : February 4, 2019
|Condition or disease||Intervention/treatment||Phase|
|Tuberculosis, Multidrug-Resistant||Drug: Linezolid Drug: Delamanid Drug: Levofloxacin Drug: Pyrazinamide Drug: Locally-used WHO-approved MDR-TB regimen in Korea||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||238 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2016|
|Estimated Primary Completion Date :||June 2021|
|Estimated Study Completion Date :||June 2021|
Active Comparator: Control Arm
Regimen is the locally-used WHO-approved MDR-TB regimen in Korea based on 2014 Korean guideline of TB management.
Drug: Locally-used WHO-approved MDR-TB regimen in Korea
Experimental: Experimental Arm
Regimen consists of only oral medication using delamanid, linezolid, levofloxacin, and pyrazinamide, for nine or twelve months depending on the time of sputum culture conversion to negative.
- Treatment success rate [ Time Frame: 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.
- Time to sputum culture conversion after treatment start [ Time Frame: through study completion, 24 months after enrollment ]To determine whether time to sputum culture conversion after treatment start is statis- tically different between the control and investigational arms, the median time will be estimated in each group using the Kaplan-Meier method, and the difference in the distribution of time to culture conversion of the two arms will be compared using the log-rank test.
- Sputum culture conversion proportion [ Time Frame: At 2 months or 6 months of treatment ]
- Treatment success [ Time Frame: At 24months after enrollment ]
- proportion of reverting to positive sputum culture after the end of treatment [ Time Frame: At 24months after enrollment ]
- Treatment success according to pyrazinamide resistance [ Time Frame: At 24months after enrollment ]
- proportion of death between the control and investigational arms [ Time Frame: At 24months after enrollment ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02619994
|Contact: Jae-Joon Yim, MDemail@example.com|
|Korea, Republic of|
|Division of Pulmonology and Critical Care Medicine, Department of Internal Medicine and Lung Institute of Medical Research Center, Seoul National University College of Medicine||Recruiting|
|Seoul, Korea, Republic of, 110-744|
|Contact: Jae-Joon Yim, MD +82-2-2072-2059 firstname.lastname@example.org|