Tuberc Respir Dis.  2020 Apr;83(2):141-146. 10.4046/trd.2019.0077.

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

Affiliations
  • 1Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Seoul National University College of Medicine, Seoul, Korea. yimjj@snu.ac.kr
  • 2Research Center, Korean Institute of Tuberculosis, Cheongju, Korea.
  • 3Division of Pulmonary and Critical Care Medicine, Department of Internal Medicine, Pusan National University Yangsan Hospital, Yangsan, Korea.
  • 4Division of Pulmonary and Critical Care Medicine, Department of Medicine, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
  • 5Division of Pulmonary and Critical Care Medicine, Asan Medical Center, University of Ulsan College of Medicine, Seoul, Korea.
  • 6Division of Pulmonology, Department of Internal Medicine, Severance Hospital, Yonsei University College of Medicine, Seoul, Korea.
  • 7Department of Internal Medicine, Chonnam National University Hospital, Gwangju, Korea.
  • 8Clinical Research Section, International Tuberculosis Research Center, Seoul, Korea.
  • 9Division of Pulmonology, Allergy and Critical Care Medicine, Department of Internal Medicine, Pusan National University Hospital, Busan, Korea.

Abstract

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.

Keyword

Nontuberculous Mycobacteria; Protocol; Registry

MeSH Terms

Cohort Studies
Follow-Up Studies
Humans
Korea*
Lung Diseases*
Mycobacterium avium Complex
Nontuberculous Mycobacteria*
Observational Study*
Prognosis
Prospective Studies
Recurrence

Reference

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; 12:642–647. PMID: 25692495.
Article
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.
Article
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; 44:733–738. PMID: 22720876.
Article
4. Lee H, Myung W, Koh WJ, Moon SM, Jhun BW. Epidemiology of nontuberculous mycobacterial infection, South Korea, 2007-2016. Emerg Infect Dis. 2019; 25:569–572. PMID: 30789139.
Article
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; 14:1069–1071. PMID: 20626955.
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. PMID: 17277290.
Article
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–ii64.
Article
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; 52:565–571. PMID: 21292659.
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. PMID: 24236749.
Article
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; 65:1077–1084. PMID: 28582488.
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 meta-analysis. Chest. 2017; 152:120–142. PMID: 28461147.
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. PMID: 29567726.
Article
13. Cook JL. Nontuberculous mycobacteria: opportunistic environmental pathogens for predisposed hosts. Br Med Bull. 2010; 96:45–59. PMID: 20977990.
Article
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. PMID: 30151192.
Article
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; 151:982–992. PMID: 27889361.
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. PMID: 27730179.
Article
Full Text Links
  • TRD
Actions
Cited
CITED
export Copy
Close
Share
  • Twitter
  • Facebook
Similar articles
Copyright © 2024 by Korean Association of Medical Journal Editors. All rights reserved.     E-mail: koreamed@kamje.or.kr