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Study of Mycobacterial Infections

National Institute of Allergy and Infectious Diseases (NIAID) · with Children's National Research Institute, University of Miami · NCT00018044

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Opens the official ClinicalTrials.gov record, with the study team’s contacts. Bored Studies doesn’t enroll anyone.

Key facts

Compensation
Not posted. Ask the study team before screening.
Who can join
Up to age 100 · All sexes
Healthy volunteers
Accepted
Study type
Observational
Target enrollment
1000
US sites recruiting
1
Study start
January 1, 2001
Record last updated
October 21, 2026

Status re-checked against ClinicalTrials.gov within the last 12 hours.

What the study is about

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.

Being studied: Clofazimine

Conditions: Mycobacterium Infections

Eligibility criteria

Copied from the official record. The study team makes the final decision at screening.

Show full criteria
  • INCLUSION CRITERIA FOR PATIENTS:

This protocol will study patients with mycobacterial infections, including those without previously identified predisposing disease processes as well as individuals with underlying malignancies. Patients with nontuberculous mycobacterial infections will be of particular interest, as we are interested in isolating and characterizing the primary immune defect(s) responsible for this infection susceptibility. Select patients with acquired immunodeficiencies or tuberculosis may also be studied if relevant host defects are suspected.

Patients must be referred to NIH with a diagnosis or suspicion of having mycobacterial infection. Male and female patients will be accepted without limitation due to age, including viable neonates. Only patients with nontuberculous mycobacterial infections without HIV infection will be considered for long-term disease management.

INCLUSION CRITERIA FOR RELATIVES

As a part of this protocol we may obtain medical records, blood work, urine, saliva or buccal swab from some blood relatives of patients, male or female including viable neonates, on the study, with the hope of isolating and characterizing the primary immune defect(s) responsible for mycobacterial infection susceptibility and if there are any genetic links seen within families. We hope to identify families with an apparent genetic susceptibility to respiratory diseases predominantly associated with P-NTM and perform whole genome sequencing within this group to identify genetic mutations accounting for this increased susceptibility.

EXCLUSION CRITERIA

None.

Recruiting US locations

  • National Institutes of Health Clinical Center

    Bethesda, MD 20892

Study contacts (from the official record)

  • Samantha A Kreuzburg, R.N. · (301) 443-2163 · samantha.kreuzburg@nih.gov
  • Steven M Holland, M.D. · (301) 402-7684 · sholland@mail.nih.gov
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Study of Mycobacterial Infections (NCT00018044) | Bored Studies