Ireland
--:--IST
Enrolling by invitation Observational

A Registry for Nontuberculous Mycobacterial Pulmonary Disease

NCT04078412 · tracked via the Priya Life Science South Korea tracker
Phase
Observational
Started
2017-11-21
Last updated
2019-11-18

Condition(s) studied

Nontuberculous Mycobacterial Pulmonary Disease

Study summary

Background:

NTM(Nontuberculous mycobacteria) pulmonary disease is increasing worldwidely, however the diagnosis and treatment of NTM pulmonary disease still has multiple obstacles. The initiation of treatment is not necessary for all patients with NTM pulmonary disease. In addition, the drugs for treatment of NTM pulmonary disease is not enough.

objective. The aim of this prospective registry for Nontuberculous mycobacterial pulmonary disease is to register the NTM pulmonary patients and analysis of the treatment outcome based on the species and to collect the blood and urine samples from the patients for exploring the biomarker for diagnosis and monitoring the NTM pulmonary disease and collect the nontuberculous mycobacterium.

Methods:

1. informed consents
2. register in cohort and collect the clinical information and serum, plasma, urine and mycobacteria
3. follow up 6 months to 1year based on the clinical situation

Analysis:

1. treatment outcome based on NTM-NET consensus statement
2. exploration of biomarker for progression and monitoring of treatment response

Eligibility

Sex
ALL
Min age
20 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. age 20 or more than 20 years 2. diagnosed by ATS criteria for NTM pulmonary disease Exclusion Criteria: 1\) not specific

Primary outcome measure(s)

  • treatment outcome based on NTM-NET consensus statement — At the end of the treatment or 12months after treatment
    1. For patients who need the treatment for NTM pulmonary disease : treatment outcome based on the NTM -NET consensus : microbiologic results, clinical symptoms and radiologic results 2. For patients who don't need the treatment for NTM pulmonary disease : progression of NTM-PD defined by clinical, microbiotic and radiologic results.

Trial sites (1)

FacilityCityRegionStatus
Department of Internal Medicine, Yonsei University College of Medicine Division of Pulmonology, Severance Hospital, Yonsei University Health System Seoul South Korea
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04078412 on ClinicalTrials.gov ↗ ← All trials in South Korea