Cited 18 times in
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
DC Field | Value | Language |
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dc.contributor.author | 강영애 | - |
dc.contributor.author | 김송이 | - |
dc.date.accessioned | 2023-03-03T02:19:49Z | - |
dc.date.available | 2023-03-03T02:19:49Z | - |
dc.date.issued | 2022-10 | - |
dc.identifier.issn | 0140-6736 | - |
dc.identifier.uri | https://ir.ymlib.yonsei.ac.kr/handle/22282913/192802 | - |
dc.description.abstract | Background: With the introduction of new anti-tuberculosis drugs, all-oral regimens with shorter treatment durations for multidrug-resistant tuberculosis have been anticipated. We aimed to investigate whether a new all-oral regimen was non-inferior to the conventional regimen including second-line anti-tuberculosis drugs for 20-24 months in the treatment of fluoroquinolone-sensitive multidrug-resistant tuberculosis. Methods: In this multicentre, randomised, open-label phase 2/3 non-inferiority trial, we enrolled men and women aged 19-85 years with multidrug-resistant tuberculosis confirmed by phenotypic or genotypic drug susceptibility tests or rifampicin-resistant tuberculosis by genotypic tests at 12 participating hospitals throughout South Korea. Participants with fluoroquinolone-resistant multidrug-resistant tuberculosis were excluded. Participants were randomly assigned (1:1) to two groups using a block randomisation, stratified by the presence of diabetes and cavitation on baseline chest radiographs. The investigational group received delamanid, linezolid, levofloxacin, and pyrazinamide for 9 months, and the control group received a conventional 20-24-month regimen, according to the 2014 WHO guidelines. The primary outcome was the treatment success rate at 24 months after treatment initiation in the modified intention-to-treat population and the per-protocol population. Participants who were "cured" and "treatment completed" were defined as treatment success following the 2014 WHO guidelines. Non-inferiority was confirmed if the lower limit of a 97·5% one-sided CI of the difference between the groups was greater than -10%. Safety data were collected for 24 months in participants who received a predefined regimen at least once. This study is registered with ClinicalTrials.gov, NCT02619994. Findings: Between March 4, 2016, and Sept 14, 2019, 214 participants were enrolled, 168 (78·5%) of whom were included in the modified intention-to-treat population. At 24 months after treatment initiation, 60 (70·6%) of 85 participants in the control group had treatment success, as did 54 (75·0%) of 72 participants in the shorter-regimen group (between-group difference 4·4% [97·5% one-sided CI -9·5% to ∞]), satisfying the predefined non-inferiority margin. No difference in safety outcomes was identified between the control group and the shorter-regimen group. Interpretation: 9-month treatment with oral delamanid, linezolid, levofloxacin, and pyrazinamide could represent a new treatment option for participants with fluoroquinolone-sensitive multidrug-resistant tuberculosis. Funding: Korea Disease Control and Prevention Agency, South Korea. | - |
dc.description.statementOfResponsibility | restriction | - |
dc.language | English | - |
dc.publisher | Elsevier | - |
dc.relation.isPartOf | LANCET | - |
dc.rights | CC BY-NC-ND 2.0 KR | - |
dc.subject.MESH | Antitubercular Agents / therapeutic use | - |
dc.subject.MESH | Drug Therapy, Combination | - |
dc.subject.MESH | Female | - |
dc.subject.MESH | Fluoroquinolones / therapeutic use | - |
dc.subject.MESH | Humans | - |
dc.subject.MESH | Levofloxacin / therapeutic use | - |
dc.subject.MESH | Linezolid / therapeutic use | - |
dc.subject.MESH | Male | - |
dc.subject.MESH | Pyrazinamide* / therapeutic use | - |
dc.subject.MESH | Treatment Outcome | - |
dc.subject.MESH | Tuberculosis, Multidrug-Resistant* / drug therapy | - |
dc.title | 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 | - |
dc.type | Article | - |
dc.contributor.college | College of Medicine (의과대학) | - |
dc.contributor.department | Dept. of Internal Medicine (내과학교실) | - |
dc.contributor.googleauthor | Jeongha Mok | - |
dc.contributor.googleauthor | Myungsun Lee | - |
dc.contributor.googleauthor | Deog Kyeom Kim | - |
dc.contributor.googleauthor | Ju Sang Kim | - |
dc.contributor.googleauthor | Byung Woo Jhun | - |
dc.contributor.googleauthor | Kyung-Wook Jo | - |
dc.contributor.googleauthor | Doosoo Jeon | - |
dc.contributor.googleauthor | Taehoon Lee | - |
dc.contributor.googleauthor | Ji Yeon Lee | - |
dc.contributor.googleauthor | Jae Seuk Park | - |
dc.contributor.googleauthor | Seung Heon Lee | - |
dc.contributor.googleauthor | Young Ae Kang | - |
dc.contributor.googleauthor | Jung-Kyu Lee | - |
dc.contributor.googleauthor | Nakwon Kwak | - |
dc.contributor.googleauthor | Joong Hyun Ahn | - |
dc.contributor.googleauthor | Tae Sun Shim | - |
dc.contributor.googleauthor | Song Yee Kim | - |
dc.contributor.googleauthor | Seungmo Kim | - |
dc.contributor.googleauthor | Kyungjong Kim | - |
dc.contributor.googleauthor | Kwang-Hyuk Seok | - |
dc.contributor.googleauthor | Soyeong Yoon | - |
dc.contributor.googleauthor | Young Ran Kim | - |
dc.contributor.googleauthor | Jisu Kim | - |
dc.contributor.googleauthor | Dahae Yim | - |
dc.contributor.googleauthor | Seokyung Hahn | - |
dc.contributor.googleauthor | Sang Nae Cho | - |
dc.contributor.googleauthor | Jae-Joon Yim | - |
dc.identifier.doi | 10.1016/S0140-6736(22)01883-9 | - |
dc.contributor.localId | A00057 | - |
dc.contributor.localId | A00626 | - |
dc.relation.journalcode | J02152 | - |
dc.identifier.eissn | 1474-547X | - |
dc.identifier.pmid | 36522208 | - |
dc.identifier.url | https://www.sciencedirect.com/science/article/pii/S0140673622018839 | - |
dc.contributor.alternativeName | Kang, Young Ae | - |
dc.contributor.affiliatedAuthor | 강영애 | - |
dc.contributor.affiliatedAuthor | 김송이 | - |
dc.citation.volume | 400 | - |
dc.citation.number | 10362 | - |
dc.citation.startPage | 1522 | - |
dc.citation.endPage | 1530 | - |
dc.identifier.bibliographicCitation | LANCET, Vol.400(10362) : 1522-1530, 2022-10 | - |
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