Delamanid, linezolid, levofloxacin, and pyrazinamide for the treatment of patients with fluoroquinolone-sensitive multidrug-resistant tuberculosis (Treatment Shortening of MDR-TB Using Existing ... View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2019-01-16

AUTHORS

Myungsun Lee, Jeongha Mok, Deog Kyeom Kim, Tae Sun Shim, Won-Jung Koh, Doosoo Jeon, Taehoon Lee, Seung Heon Lee, Ju Sang Kim, Jae Seuk Park, Ji Yeon Lee, Song Yee Kim, Jae Ho Lee, Kyung-Wook Jo, Byung Woo Jhun, Young Ae Kang, Joong Hyun Ahn, Chang-Ki Kim, Soyoun Shin, Taeksun Song, Sung Jae Shin, Young Ran Kim, Heejung Ahn, Seokyung Hahn, Ho Jeong Won, Ji Yeon Jang, Sang Nae Cho, Jae-Joon Yim

ABSTRACT

BACKGROUND: 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. More... »

PAGES

57

References to SciGraph publications

Journal

TITLE

Trials

ISSUE

1

VOLUME

20

Author Affiliations

  • Clinical Research Section, International Tuberculosis Research Center, 247, Jangchungdan-ro, Jung-gu, Seoul, 04564 Republic of Korea
  • Division of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Pusan National University Hospital, 179, Gudeok-ro, Seo-gu, Busan, 49241 Republic of Korea
  • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Boramae Medical Center, 20, Boramae-ro 5-gil, Dongjak-gu, Seoul, 07061 Republic of Korea
  • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Asan Medical Center, 88, Olympic-ro 43-gil, Songpa-gu, Seoul, 05505 Republic of Korea
  • Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, 81, Irwon-ro, Gangnam-gu, Seoul, 06351 Republic of Korea
  • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital, 20, Geumo-ro, Mulgeum-eup, Yangsan-si, Gyeongsangnam-do 50612 Republic of Korea
  • Department of Pulmonology, Ulsan University Hospital, University of Ulsan College of Medicine, 877, Bangeojinsunhwando-ro, Dong-gu, Ulsan, 44033 Republic of Korea
  • Department of Pulmonology, Korea University Ansan Hospital, 123, Jeokgeum-ro, Danwon-gu, Ansan, Gyeonggi-do 15355 Republic of Korea
  • Department of Pulmonary and Critical Care Medicine, Department of Internal Medicine, The Catholic University of Korea, Incheon St. Mary’s Hospital, 56, Dongsu-ro, Bupyeong-gu, Incheon, 21431 Republic of Korea
  • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Dankook University Hospital, 201, Manghyang-ro, Dongnam-gu, Cheonan-si, Chungcheongnam-do 31116 Republic of Korea
  • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, National Medical Center, 245, Eulji-ro, Jung-gu, Seoul, 04564 Republic of Korea
  • Division of Pulmonology, Department of Internal Medicine, Institute of Chest Diseases, Severance Hospital, Yonsei University College of Medicine, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, 03722 Republic of Korea
  • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University Bundang Hospital, 82, Gumi-ro 173beon-gil, Bundang-gu, Seongnam-si, Gyeonggi-do 13620 Republic of Korea
  • Seoul Clinical Laboratories, 13, Heungdeok 1-ro, Giheung-gu, Yongin, Gyeonggi-do 16954 Republic of Korea
  • Laboratory Medicine Center, The Korean Institute of Tuberculosis, 168-5, Osongsaengmyeong 4-ro, Osong-eup, Heungdeok-gu, Cheongju-si, Chungcheongbuk-do 28158 Republic of Korea
  • Institute of Infectious Disease and Molecular Medicine, University of Cape Town, Rondebosch 7701, Cape Town, South Africa
  • Department of Microbiology, Brain Korea 21 PLUS Project for Medical Science, Yonsei University College of Medicine, 50-1, Yonsei-ro, Seodaemun-gu, Seoul, 03722 Republic of Korea
  • Medical Research Collaborating Center, Seoul National University Hospital, 101, Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea
  • Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, 103, Daehak-ro, Jongno-gu, Seoul, 03080 Republic of Korea
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1186/s13063-018-3053-1

    DOI

    http://dx.doi.org/10.1186/s13063-018-3053-1

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1111461217

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/30651149


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