Clinical trial Recruiting at 1 site Observational Ages Any age to 100

Examining Mycobacterial Infections

Official title: Natural History, Genetics, Phenotype, and Treatment of Mycobacterial Infections

Run by National Institutes of Health Clinical Center (CC) · NCT00018044 · Data updated 2026-11-12

This study is trying to learn more about non-tuberculous mycobacterial infections in people with certain health conditions to see how they affect symptoms and treatment options.

Quick facts

Study typeObservational
AgesAny age to 100 Years
SexAll
Enrollment1000 (estimated)
SponsorNational Institutes of Health Clinical Center (CC)
NIH
Locations1 site (Bethesda, Maryland)
StatusRecruiting
StartedJanuary 1, 2001
Registry record updatedNovember 9, 2026
Trial IDNCT00018044 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates include individuals diagnosed or suspected to have non-tuberculous mycobacterial infections, cystic fibrosis, or Job syndrome.

Probably not a fit

Patients with mycobacterial infections who are also HIV positive may not benefit from this study's long-term management focus.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on understanding the symptoms, progression, and treatment of non-tuberculous mycobacterial (NTM) infections, which can lead to recurrent lung infections and other health issues. It will involve patients with diagnosed or suspected NTM infections, cystic fibrosis, or Job syndrome, who will undergo a series of medical evaluations including imaging studies and genetic testing. The research aims to identify genetic factors that may contribute to susceptibility to these infections, potentially leading to improved therapeutic strategies.

Why it matters

Potential benefit: If successful, this study could lead to better understanding and management of NTM infections, improving patient outcomes.

How similar studies have gone: Other studies have shown success in understanding mycobacterial infections, but this specific approach to identifying genetic susceptibility factors is relatively novel.

Who can join: the full rules

Show full inclusion / exclusion 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.

Where it's running

  • National Institutes of Health Clinical Center
    Bethesda, Maryland, United States
    Recruiting

Study contacts

  • Principal investigator: Steven M Holland, M.D. — National Institute of Allergy and Infectious Diseases (NIAID)
  • Study coordinator: Samantha A Kreuzburg, R.N.
  • Email: samantha.kreuzburg@nih.gov
  • Phone: (301) 443-2163

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

  • Investigation of Nontuberculous Mycobacteria Outbreaks in Healthcare Settings

    This study is trying to find out if nontuberculous mycobacteria infections in healthcare settings are spreading between patients and where they might be coming from.

    Recruiting University of North Carolina, Chapel Hill · Chapel Hill, North Carolina · NCT06155747

  • Gene expression profiles in spinal tuberculosis

    This study is trying to see if different gene patterns in spinal tuberculosis can help doctors better understand and treat the disease, especially in people with HIV.

    Recruiting University of Cape Town · Cape Town, Western Cape · NCT05610098

  • Understanding the natural history of tuberculosis

    This study is trying to learn more about tuberculosis by collecting samples and monitoring treatment in people with active or latent TB to improve how we understand and treat the disease.

    Recruiting National Institutes of Health Clinical Center (CC) · Bethesda, Maryland · NCT01212003

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.