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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 | Mok, Jeongha | - |
dc.contributor.author | Lee, Myungsun | - |
dc.contributor.author | Kim, Deog Kyeom | - |
dc.contributor.author | Kim, Ju Sang | - |
dc.contributor.author | Jhun, Byung Woo | - |
dc.contributor.author | Jo, Kyung-Wook | - |
dc.contributor.author | Jeon, Doosoo | - |
dc.contributor.author | Lee, Taehoon | - |
dc.contributor.author | Lee, Ji Yeon | - |
dc.contributor.author | Park, Jae Seuk | - |
dc.contributor.author | Lee, Seung Heon | - |
dc.contributor.author | Kang, Young Ae | - |
dc.contributor.author | Lee, Jung-Kyu | - |
dc.contributor.author | Kwak, Nakwon | - |
dc.contributor.author | Ahn, Joong Hyun | - |
dc.contributor.author | Shim, Tae Sun | - |
dc.contributor.author | Kim, Song Yee | - |
dc.contributor.author | Kim, Seungmo | - |
dc.contributor.author | Kim, Kyungjong | - |
dc.contributor.author | Seok, Kwang-Hyuk | - |
dc.contributor.author | Yoon, Soyeong | - |
dc.contributor.author | Kim, Young Ran | - |
dc.contributor.author | Kim, Jisu | - |
dc.contributor.author | Yim, Dahae | - |
dc.contributor.author | Hahn, Seokyung | - |
dc.contributor.author | Cho, Sang Nae | - |
dc.contributor.author | Yim, Jae-Joon | - |
dc.date.accessioned | 2023-02-27T04:51:54Z | - |
dc.date.available | 2023-02-27T04:51:54Z | - |
dc.date.created | 2023-01-13 | - |
dc.date.created | 2023-01-13 | - |
dc.date.created | 2023-01-13 | - |
dc.date.issued | 2022-10 | - |
dc.identifier.citation | The Lancet, Vol.400 No.10362, pp.1522-1530 | - |
dc.identifier.issn | 0140-6736 | - |
dc.identifier.uri | https://hdl.handle.net/10371/189228 | - |
dc.description.abstract | © 2022 Elsevier LtdBackground: 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.language | 영어 | - |
dc.publisher | The Lancet Publishing Group | - |
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.identifier.doi | 10.1016/S0140-6736(22)01883-9 | - |
dc.citation.journaltitle | The Lancet | - |
dc.identifier.wosid | 000923383000025 | - |
dc.identifier.scopusid | 2-s2.0-85140470877 | - |
dc.citation.endpage | 1530 | - |
dc.citation.number | 10362 | - |
dc.citation.startpage | 1522 | - |
dc.citation.volume | 400 | - |
dc.description.isOpenAccess | N | - |
dc.contributor.affiliatedAuthor | Kim, Deog Kyeom | - |
dc.contributor.affiliatedAuthor | Yim, Jae-Joon | - |
dc.type.docType | Article | - |
dc.description.journalClass | 1 | - |
dc.subject.keywordPlus | MOXIFLOXACIN | - |
dc.subject.keywordPlus | OUTCOMES | - |
dc.subject.keywordPlus | BEDAQUILINE | - |
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