drugset / Trial / NCT02619994
Treatment Shortening of MDR-TB Using Existing and New Drugs
Phase 2
Completed
214 enrolled
Seoul National University Hospital
Asan Medical Center · collabDankook University · collabIncheon St.Mary's Hospital · collabInternational Tuberculosis Research Center · collabKorea University Ansan Hospital · collabKorean Center for Disease Control and Prevention · collabKorean Institute of Tuberculosis · collabNational Medical Center, Seoul · collabPusan National University Hospital · collabPusan National University Yangsan Hospital · collabSMG-SNU Boramae Medical Center · collabSamsung Medical Center · collabSeverance Hospital · collabUlsan University Hospital · collab
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-01
- Primary completion
- 2021-06
- Completion
- 2021-06
Publications
- Mok J, Lee M, Kim DK, Kim JS, Jhun BW, Jo KW, Jeon D, Lee T, Lee JY, Park JS, Lee SH, Kang YA, Lee JK, Kwak N, Ahn JH, Shim TS, Kim SY, Kim S, Kim K, Seok KH, Yoon S, Kim YR, Kim J, Yim D, Hahn S, Cho SN, Yim JJ; MDR-END investigators. 9 months of delamanid, linezolid, levofloxacin, and pyrazinamide versus conventional therapy for treatment of fluoroquinolone-sensitive multidrug-resistant tuberculosis (MDR-END): a multicentre, randomised, open-label phase 2/3 non-inferiority trial in South Korea. Lancet. 2022 Oct 29;400(10362):1522-1530. doi: 10.1016/S0140-6736(22)01883-9.
- Lee M, Mok J, Kim DK, Shim TS, Koh WJ, Jeon D, Lee T, Lee SH, Kim JS, Park JS, Lee JY, Kim SY, Lee JH, Jo KW, Jhun BW, Kang YA, Ahn JH, Kim CK, Shin S, Song T, Shin SJ, Kim YR, Ahn H, Hahn S, Won HJ, Jang JY, Cho SN, Yim JJ. Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing and New Drugs, MDR-END): study protocol for a phase II/III, multicenter, randomized, open-label clinical trial. Trials. 2019 Jan 16;20(1):57. doi: 10.1186/s13063-018-3053-1.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Delamanid | Small molecule | 100 mg | Oral |
| Subject | Levofloxacin | Small molecule | 750 mg | Oral |
| Subject | Levofloxacin | Small molecule | 1000 mg | Oral |
| Subject | Linezolid | Other / unclassified | 300 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 1000 mg | Oral |
| Subject | Pyrazinamide | Small molecule | 2000 mg | Oral |