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

Tuberculosis and Respiratory Diseases 2020년 83권 2호 p.141 ~ 146
곽낙원, 최홍조, 전두수, 전병우, 조경욱, 강영애, 권용수, Lee Myung-Sun, 목정하, 심태선, 신홍준, Whang Jake, 임재준,
소속 상세정보
곽낙원 ( Kwak Nak-Won ) - Seoul National University College of Medicine Department of Internal Medicine
최홍조 ( Choi Hong-Jo ) - Korean Institute of Tuberculosis Research Center
전두수 ( Jeon Doo-Soo ) - Pusan National University Yangsan Hospital Department of Internal Medicine
전병우 ( Jhun Byung-Woo ) - Sungkyunkwan University School of Medicine Samsung Medical Center Department of Medicine
조경욱 ( Jo Kyung-Wook ) - University of Ulsan College of Medicine Asan Medical Center Department of Internal Medicine
강영애 ( Kang Young-Ae ) - Yonsei University College of Medicine Severance Hospital Department of Internal Medicine
권용수 ( Kwon Yong-Soo ) - Chonnam National University Hospital Department of Internal Medicine
 ( Lee Myung-Sun ) - International Tuberculosis Research Center Clinical Research Section
목정하 ( Mok Jeong-Ha ) - Pusan National University Hospital Department of Internal Medicine
심태선 ( Shim Tae-Sun ) - University of Ulsan College of Medicine Asan Medical Center Department of Internal Medicine
신홍준 ( Shin Hong-Joon ) - Chonnam National University Hospital Department of Internal Medicine
 ( Whang Jake ) - Korean Institute of Tuberculosis Research Center
임재준 ( Yim Jae-Joon ) - Seoul National University College of Medicine Department of Internal Medicine

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.

키워드

Nontuberculous Mycobacteria; Protocol; Registry

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