Clinical Trial Summary
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.