Protocol of a Nationwide Observational Study among Patients with Nontuberculous Mycobacterium Pulmonary Disease in South Korea (NTM-KOREA)
- Author:
Nakwon KWAK
1
;
Hongjo CHOI
;
Doosoo JEON
;
Byung Woo JHUN
;
Kyung Wook JO
;
Young Ae KANG
;
Yong Soo KWON
;
Myungsun LEE
;
Jeongha MOK
;
Tae Sun SHIM
;
Hong Joon SHIN
;
Jake WHANG
;
Jae Joon YIM
Author Information
- Publication Type:Original Article
- From:Tuberculosis and Respiratory Diseases 2020;83(2):141-146
- CountryRepublic of Korea
- Language:English
-
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.