Study of Mycobacterial Infections

Part of paid clinical trials in Bethesda, Maryland.

Sponsor
National Institute of Allergy and Infectious Diseases (NIAID)
Study ID
NCT00018044
Status
Recruiting
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Conditions

  • Mycobacterium Infections

Eligibility Criteria

Sex
ALL
Age
N/A - 100 Years
Healthy Volunteers
Accepted

Interventions

  • Clofazimine — DRUG

Study Details

This study will examine the symptoms, course of disease and treatment of non-tuberculous mycobacterial (NTM) infections, as well as the genetics involved in these infections. Patients with NTM have recurrent lung infections and sometimes infections of the skin and other organs as well. They may also have curvature of the spine, barrel chest, and heart valve weakness. The study will compare the features of NTM with those of Job syndrome and cystic fibrosis, other diseases involving recurrent infections of the lungs and possibly other organs. Patients with diagnosed or suspected non-tuberculous mycobacterial infection, cystic fibrosis or Job syndrome may be eligible for this study. All participants will have a medical and family history, blood and urine tests, imaging studies that may include X-rays, computed tomography (CT) or magnetic resonance imaging (MRI) scans, and DNA and other genetic studies. In addition, all patients with Job syndrome and cystic fibrosis, and patients with NTM who have lung disease undergo the following procedures: * Scoliosis survey X-rays of the spine to look for curvature or other abnormalities of the spinal column * Echocardiography imaging test that uses sound waves to examine the heart chambers and valves * Electrocardiogram measurement of the electrical activity of the heart * Pulmonary function tests breathing tests to measure how much air the patient can move into and out of the lungs * Body measurements measurements of height, weight, arm span, finger length, etc. * Joint function assessment of joint mobility using different maneuvers to test flexibility of joints and ligaments * Examination of physical features that might be associated with NTM, such as high arched palate of the mouth, flat feet, or certain skin features * Dermatology (skin) examination for reactive skin conditions or other skin problems and possibly a skin biopsy (surgical removal of a small skin tissue sample for microscopic examination) * Interview with genetics specialist These tests may require several days to complete. Patients with NTM will also be examined by a cystic fibrosis specialist and may have a sweat test. In addition, NTM patients will be asked to return to NIH every year for 5 years for follow-up tests, if medically indicated, including CT of the chest, scoliosis survey and examination by other specialists.

Key Dates

Start date
Jan 1, 2001
Status verified
Jun 2026

Study Design

Enrollment
1,000 participants (estimated)

Arms

  • Arm: Patient Relatives
    Blood relatives of enrolled patients
  • Arm: Patients
    Patients with mycobacterial infections

Primary Outcome Measure

Collect patients with nontuberculous mycobacterial infections in order to identify known and novel immune defects, characterize the natural history of these infections in the setting of the best possible standard therapy, and explore the connect... [ Time Frame: ongoing ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Institutes of Health Clinical CenterBethesdaMaryland20892-

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National Institutes of Health Clinical Center· Bethesda, MD

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