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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

DC Field Value Language
dc.contributor.authorLee, Myungsun-
dc.contributor.authorMok, Jeongha-
dc.contributor.authorKim, Deog Kyeom-
dc.contributor.authorShim, Tae Sun-
dc.contributor.authorKoh, Won-Jung-
dc.contributor.authorJeon, Doosoo-
dc.contributor.authorLee, Taehoon-
dc.contributor.authorLee, Seung Hoon-
dc.contributor.authorKim, Ju Sang-
dc.contributor.authorPark, Jae Seuk-
dc.contributor.authorLee, Ji Yeon-
dc.contributor.authorKim, Song Yee-
dc.contributor.authorLee, Jae Ho-
dc.contributor.authorJo, Kyung-Wook-
dc.contributor.authorJhun, Byung Woo-
dc.contributor.authorKang, Young Ae-
dc.contributor.authorAhn, Joong Hyun-
dc.contributor.authorKim, Chang-Ki-
dc.contributor.authorShin, Soyoun-
dc.contributor.authorSong, Taeksun-
dc.contributor.authorShin, Sung Jae-
dc.contributor.authorKim, Young Ran-
dc.contributor.authorAhn, Heejung-
dc.contributor.authorHahn, Seokyung-
dc.contributor.authorWon, Ho Jeong-
dc.contributor.authorJang, Ji Yeon-
dc.contributor.authorCho, Sang Nae-
dc.contributor.authorYim, Jae-Joon-
dc.date.accessioned2019-03-14T05:01:29Z-
dc.date.available2019-03-14T14:02:17Z-
dc.date.issued2019-01-16-
dc.identifier.citationTrials, 20(1):57ko_KR
dc.identifier.issn1745-6215-
dc.identifier.urihttp://hdl.handle.net/10371/147099-
dc.description.abstractBackground
Treatment success rates of multidrug-resistant tuberculosis (MDR-TB) remain unsatisfactory, and long-term use of second-line anti-TB drugs is accompanied by the frequent occurrence of adverse events, low treatment compliance, and high costs. The development of new efficient regimens with shorter treatment durations for MDR-TB will solve these issues and improve treatment outcomes.

Methods
This study is a phase II/III, multicenter, randomized, open-label clinical trial of non-inferiority design comparing a new regimen to the World Health Organization-endorsed conventional regimen for fluoroquinolone-sensitive MDR-TB. The control arm uses a conventional treatment regimen with second-line drugs including injectables for 20–24 months. The investigational arm uses a new shorter regimen including delamanid, linezolid, levofloxacin, and pyrazinamide for 9 or 12 months depending on time to sputum culture conversion. The primary outcome is the treatment success rate at 24 months after treatment initiation. Secondary outcomes include time to sputum culture conversion on liquid and solid media, proportions of sputum culture conversion on liquid media after 2 and 6 months of treatment, treatment success rate according to pyrazinamide resistance, and occurrence of adverse events grade 3 and above as evaluated by the Common Terminology Criteria for Adverse Events. Based on an α = 0.025 level of significance (one-sided test), a power of 80%, and a < 10% difference in treatment success rate between the control and investigational arms (80% vs. 70%) when the anticipated actual success rate in the treatment group is assumed to be 90%, the number of participants needed per arm to show non-inferiority of the investigational regimen was calculated as 48. Additionally, assuming the proportion of fluoroquinolone-susceptible MDR-TB among participants as 50%, and 5% loss to follow-up, the number of participants is calculated as N/( 0.50 × 0.95), resulting in 102 persons per group (204 in total).

Discussion
This trial will reveal the effectiveness and safety of a new shorter regimen comprising four oral drugs, including delamanid, linezolid, levofloxacin, and pyrazinamide, for the treatment of fluoroquinolone-sensitive MDR-TB. Results from this trial will provide evidence for adopting a shorter and more convenient treatment regimen for MDR-TB.

Trial registration
ClincalTrials.gov, NCT02619994. Registered on 2 December 2015.
ko_KR
dc.description.sponsorshipThis study was supported by a grant from the Korea Centers for Disease Control and Prevention, Republic of Korea (#2015-177). Linezolid (Zyvox®) was donated by Pfizer Inc. (New York, NY, USA). Delamanid (Deltyba®) was donated by Korea Otsuka Pharmaceutical Co. Ltd. The funder and donors had no role in study design, data collection and analysis, decision to publish, or preparation of the manuscript.ko_KR
dc.language.isoenko_KR
dc.publisherBioMed Centralko_KR
dc.subjectTuberculosisko_KR
dc.subjectMultidrug-resistant tuberculosisko_KR
dc.subjectMulticenter randomized trialko_KR
dc.subjectNon-inferiorityko_KR
dc.subjectShorter regimenko_KR
dc.subjectDelamanidko_KR
dc.subjectLinezolidko_KR
dc.titleDelamanid, 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 trialko_KR
dc.typeArticleko_KR
dc.contributor.AlternativeAuthor이명선-
dc.contributor.AlternativeAuthor목정하-
dc.contributor.AlternativeAuthor김덕겸-
dc.contributor.AlternativeAuthor심태선-
dc.contributor.AlternativeAuthor고원정-
dc.contributor.AlternativeAuthor전두수-
dc.contributor.AlternativeAuthor이태훈-
dc.contributor.AlternativeAuthor이승헌-
dc.contributor.AlternativeAuthor김주상-
dc.contributor.AlternativeAuthor박재석-
dc.contributor.AlternativeAuthor이지연-
dc.contributor.AlternativeAuthor김송이-
dc.contributor.AlternativeAuthor이재호-
dc.contributor.AlternativeAuthor조경욱-
dc.contributor.AlternativeAuthor전병우-
dc.contributor.AlternativeAuthor강영애-
dc.contributor.AlternativeAuthor안중현-
dc.contributor.AlternativeAuthor김창기-
dc.contributor.AlternativeAuthor신소연-
dc.contributor.AlternativeAuthor송택선-
dc.contributor.AlternativeAuthor신성재-
dc.contributor.AlternativeAuthor김영란-
dc.contributor.AlternativeAuthor안희정-
dc.contributor.AlternativeAuthor한서경-
dc.contributor.AlternativeAuthor원호정-
dc.contributor.AlternativeAuthor장지연-
dc.contributor.AlternativeAuthor조상래-
dc.contributor.AlternativeAuthor임재준-
dc.identifier.doi10.1186/s13063-018-3053-1-
dc.language.rfc3066en-
dc.rights.holderThe Author(s).-
dc.date.updated2019-01-20T04:16:51Z-
Appears in Collections:
College of Medicine/School of Medicine (의과대학/대학원)Internal Medicine (내과학전공)Journal Papers (저널논문_내과학전공)
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