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Study of Nontuberculous Mycobacterial Lung Disease

This study is currently recruiting participants.
Verified October 2016 by Won-Jung Koh, Samsung Medical Center
Sponsor:
ClinicalTrials.gov Identifier:
NCT00970801
First Posted: September 2, 2009
Last Update Posted: October 18, 2016
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Won-Jung Koh, Samsung Medical Center
  Purpose

The incidence of pulmonary disease caused by nontuberculous mycobacteria (NTM) has been increasing, and a substantial proportion of these patients have no preexisting lung disease and no demonstrable immunodeficiency. These patients are predominantly nonsmoking elderly women. High-resolution computed tomography scans revealed the characteristic findings of multifocal bronchiectasis combined with multiple small nodules. NTMs are ubiquitous environmental organisms. Because exposure to these organisms is universal and the occurrence of the disease is rare, normal host defense mechanisms must be effective enough to prevent the infection.

All patients with NTM lung disease do not need to receive long-term antibiotic treatment. As the American Thoracic Society guidelines point out, one of the most difficult questions may be when to start antibiotic therapy in patients with NTM lung disease. The decision to begin treatment is made by weighing the anticipated benefits and risks. The decision is relatively easy in patients with profound symptoms and destructive lesions; however, the decision is difficult in patients with mild symptoms and non-advanced lesions. Factors that must be considered include the patients' age, whether the symptoms are mild or equivocal, and the presence of comorbidities. In all cases, close observation is necessary if treatment is not performed. However, few studies have shown that patients with certain characteristics show disease progression.

The treatment of NTM pulmonary disease depends on the infecting species, but decisions concerning the institution of treatment are never easy. Treatment requires the use of multiple drugs for 18 to 24 months. Thus, treatment is expensive, often has significant side effects, and is frequently not curative. Therefore, clinicians should be confident that there is sufficient pathology to warrant prolonged, multidrug treatment regimens. In all of the situations, outcomes can be best optimized only when clinicians, radiologists, and laboratories work cooperatively.

This study will examine why some people are more susceptible to NTM lung disease and why some people of NTM lung disease are more difficult to treat. This study will examine the patient and bacterial characteristics, course of disease and treatment of NTM infections, as well as the genetics involved in these infections.

Patients with diagnosed NTM lung disease may be eligible for this study. All participants will have a medical and family history, blood tests, imaging studies that may include X-rays, computed tomography (CT) scans, and genetic and serologic studies. The aim of this study is to identify patient and bacterial characteristics that contribute to disease susceptibility, disease progression, and treatment failure. Subjects are recruited from among patients who are diagnosed to have NTM lung disease at the Samsung Medical Center in the Republic of Korea.


Condition
Nontuberculous Mycobacterial Lung Disease

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Identification of Host Susceptibility Factors and Development of Biomarkers for Diagnosis, Prognosis and Treatment of Nontuberculous Mycobacterial Lung Disease

Resource links provided by NLM:


Further study details as provided by Won-Jung Koh, Samsung Medical Center:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: weekly ]

Secondary Outcome Measures:
  • disease susceptibility, disease progression, treatment failure [ Time Frame: weekly ]

Estimated Enrollment: 300
Study Start Date: January 2008
Estimated Study Completion Date: December 2019
Estimated Primary Completion Date: December 2017 (Final data collection date for primary outcome measure)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 90 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients visited Samsung Medical Hospital
Criteria

Inclusion Criteria:

  • Patients who fulfill the diagnostic criteria of NTM lung disease

Exclusion Criteria:

  • Non-applicable
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00970801


Contacts
Contact: Won-Jung Koh, MD 822-3410-3429 wjkoh@skku.edu

Locations
Korea, Republic of
Samsung Medical Center Recruiting
Seoul, Korea, Republic of, 135-710
Contact: Won-Jung Koh, MD    822-3410-3429    wjkoh@skku.edu   
Sponsors and Collaborators
Samsung Medical Center
Investigators
Principal Investigator: Won-Jung Koh, MD Samsung Medical Center
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Won-Jung Koh, MD, PhD, Associated professor, school of medicine, sungkyunkwan university, Samsung Medical Center
ClinicalTrials.gov Identifier: NCT00970801     History of Changes
Other Study ID Numbers: 2008-09-016
First Submitted: September 1, 2009
First Posted: September 2, 2009
Last Update Posted: October 18, 2016
Last Verified: October 2016

Keywords provided by Won-Jung Koh, Samsung Medical Center:
Atypical mycobacteria

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases