Study of Nontuberculous Mycobacterial Lung Disease

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Samsung Medical Center
Sponsor:
Information provided by (Responsible Party):
Won-Jung Koh, Samsung Medical Center
ClinicalTrials.gov Identifier:
NCT00970801
First received: September 1, 2009
Last updated: December 14, 2012
Last verified: December 2012
  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

Further study details as provided by Samsung Medical Center:

Primary Outcome Measures:
  • All cause mortality [ Time Frame: weekly ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • disease susceptibility, disease progression, treatment failure [ Time Frame: weekly ] [ Designated as safety issue: No ]

Estimated Enrollment: 300
Study Start Date: January 2008
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
  Eligibility

Ages Eligible for Study:   20 Years to 90 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Samsung Medical Center

Additional 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
Study First Received: September 1, 2009
Last Updated: December 14, 2012
Health Authority: Korea: Ministry for Health, Welfare and Family Affairs

Keywords provided by Samsung Medical Center:
Atypical mycobacteria

Additional relevant MeSH terms:
Lung Diseases
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on September 18, 2014