DOI QR코드

DOI QR Code

Protocol of a Nationwide Observational Study among Patients with Nontuberculous Mycobacterium Pulmonary Disease in South Korea (NTM-KOREA)

  • Kwak, Nakwon (Division of Pulmonar y and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine) ;
  • Choi, Hongjo (Research Center, Korean Institute of Tuberculosis) ;
  • Jeon, Doosoo (Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital) ;
  • Jhun, Byung Woo (Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine) ;
  • Jo, Kyung-Wook (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Kang, Young Ae (Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine) ;
  • Kwon, Yong-Soo (Department of Internal Medicine, Chonnam National University Hospital) ;
  • Lee, Myungsun (Clinical Research Section, International Tuberculosis Research Center) ;
  • Mok, Jeongha (Division of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Pusan National University Hospital) ;
  • Shim, Tae-Sun (Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine) ;
  • Shin, Hong-Joon (Department of Internal Medicine, Chonnam National University Hospital) ;
  • Whang, Jake (Research Center, Korean Institute of Tuberculosis) ;
  • Yim, Jae-Joon (Division of Pulmonar y and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine)
  • 투고 : 2019.10.31
  • 심사 : 2020.01.02
  • 발행 : 2020.04.30

초록

Background: The burden of nontuberculous mycobacterial (NTM) pulmonary disease (PD) is increasing globally. To understand the treatment outcomes and prognosis of NTM-PD, a unified registry is needed. In this project, we aim to construct a multicenter prospective observational cohort with NTM-PD in South Korea (NTM-KOREA). Methods: The primary objective of this study is to analyze treatment outcomes according to the species. In addition, recurrence rate, adverse events, the impact of each drug on treatment outcomes as well as the impact of characteristics of mycobacteriology will be analyzed. The inclusion criteria for the study are as follows: fulfilling the criteria for NTM-PD having one of the following etiologic organisms: Mycobacterium avium complex, M. abscessus subspecies abscessus, M. abscessus subspecies massiliense, or M. kansasii; receiving the first treatment for NTM-PD after enrollment; age >20 years; and consenting to participate in the study. Seven institutions will participate in patient enrollment and about 500 patients are expected to be enrolled. Participants will be recruited from 1 March 2020 until 19 March 2024 and will be observed through 19 March 2029. During the follow-up period, participants' clinical course will be tracked and their clinical data as well as NTM isolates will be collected. Conclusion: NTM-KOREA will be the first nationwide observational cohort for NTM-PD in South Korea. It will provide the information to optimize treatment modalities and will contribute to deeper understanding of the treatment outcomes and long-term prognosis of patients with NTM-PD in South Korea.

키워드

참고문헌

  1. Henkle E, Hedberg K, Schafer S, Novosad S, Winthrop KL. Population-based incidence of pulmonary nontuberculous mycobacterial disease in Oregon 2007 to 2012. Ann Am Thorac Soc 2015;12:642-7. https://doi.org/10.1513/AnnalsATS.201412-559OC
  2. Koh WJ, Chang B, Jeong BH, Jeon K, Kim SY, Lee NY, et al. Increasing recovery of nontuberculous mycobacteria from respiratory specimens over a 10-year period in a tertiary referral hospital in South Korea. Tuberc Respir Dis 2013;75:199-204. https://doi.org/10.4046/trd.2013.75.5.199
  3. Lee SK, Lee EJ, Kim SK, Chang J, Jeong SH, Kang YA. Changing epidemiology of nontuberculous mycobacterial lung disease in South Korea. Scand J Infect Dis 2012;44:733-8. https://doi.org/10.3109/00365548.2012.681695
  4. Lee H, Myung W, Koh WJ, Moon SM, Jhun BW. Epidemiology of nontuberculous mycobacterial infection, South Korea, 2007-2016. Emerg Infect Dis 2019;25:569-72. https://doi.org/10.3201/eid2503.181597
  5. Park YS, Lee CH, Lee SM, Yang SC, Yoo CG, Kim YW, et al. Rapid increase of non-tuberculous mycobacterial lung diseases at a tertiary referral hospital in South Korea. Int J Tuberc Lung Dis 2010;14:1069-71.
  6. Griffith DE, Aksamit T, Brown-Elliott BA, Catanzaro A, Daley C, Gordin F, et al. An official ATS/IDSA statement: diagnosis, treatment, and prevention of nontuberculous mycobacterial diseases. Am J Respir Crit Care Med 2007;175:367-416. https://doi.org/10.1164/rccm.200604-571ST
  7. Haworth CS, Banks J, Capstick T, Fisher AJ, Gorsuch T, Laurenson IF, et al. British Thoracic Society guidelines for the management of non-tuberculous mycobacterial pulmonary disease (NTM-PD). Thorax 2017;72:ii1-64. https://doi.org/10.1136/thoraxjnl-2016-209170
  8. Jarand J, Levin A, Zhang L, Huitt G, Mitchell JD, Daley CL. Clinical and microbiologic outcomes in patients receiving treatment for Mycobacterium abscessus pulmonary disease. Clin Infect Dis 2011;52:565-71. https://doi.org/10.1093/cid/ciq237
  9. Adjemian J, Prevots DR, Gallagher J, Heap K, Gupta R, Griffith D. Lack of adherence to evidence-based treatment guidelines for nontuberculous mycobacterial lung disease. Ann Am Thorac Soc 2014;11:9-16. https://doi.org/10.1513/AnnalsATS.201304-085OC
  10. Kwak N, Park J, Kim E, Lee CH, Han SK, Yim JJ. Treatment outcomes of Mycobacterium avium complex lung disease: a systematic review and meta-analysis. Clin Infect Dis 2017;65:1077-84. https://doi.org/10.1093/cid/cix517
  11. Diel R, Ringshausen F, Richter E, Welker L, Schmitz J, Nienhaus A. Microbiological and clinical outcomes of treating non-Mycobacterium avium complex nontuberculous mycobacterial pulmonary disease: a systematic review and metaanalysis. Chest 2017;152:120-42. https://doi.org/10.1016/j.chest.2017.04.166
  12. van Ingen J, Aksamit T, Andrejak C, Bottger EC, Cambau E, Daley CL, et al. Treatment outcome definitions in nontuberculous mycobacterial pulmonary disease: an NTM-NET consensus statement. Eur Respir J 2018;51:1800170. https://doi.org/10.1183/13993003.00170-2018
  13. Cook JL. Nontuberculous mycobacteria: opportunistic environmental pathogens for predisposed hosts. Br Med Bull 2010;96:45-59. https://doi.org/10.1093/bmb/ldq035
  14. Aliberti S, Codecasa LR, Gori A, Sotgiu G, Spotti M, Di Biagio A, et al. The Italian registry of pulmonary non-tuberculous mycobacteria - IRENE: the study protocol. Multidiscip Respir Med 2018;13(Suppl 1):33. https://doi.org/10.1186/s40248-018-0141-8
  15. Aksamit TR, O'Donnell AE, Barker A, Olivier KN, Winthrop KL, Daniels ML, et al. Adult patients with bronchiectasis: a first look at the US Bronchiectasis Research Registry. Chest 2017;151:982-92. https://doi.org/10.1016/j.chest.2016.10.055
  16. Chalmers JD, Aliberti S, Polverino E, Vendrell M, Crichton M, Loebinger M, et al. The EMBARC European Bronchiectasis Registry: protocol for an international observational study. ERJ Open Res 2016;2:00081-2015.