Examining Mycobacterial Infections
Natural History, Genetics, Phenotype, and Treatment of Mycobacterial Infections
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 type | Observational |
|---|---|
| Enrollment | 1000 (estimated) |
| Ages | N/A to 100 Years |
| Sex | All |
| Sponsor | National Institutes of Health Clinical Center (CC) NIH |
| Locations | 1 site (Bethesda, Maryland) |
| Trial ID | NCT00018044 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include individuals diagnosed or suspected to have non-tuberculous mycobacterial infections, cystic fibrosis, or Job syndrome.
Not a fit: Patients with mycobacterial infections who are also HIV positive may not benefit from this study's long-term management focus.
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 performed: Other studies have shown success in understanding mycobacterial infections, but this specific approach to identifying genetic susceptibility factors is relatively novel.
Eligibility criteria
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 limitations due to age. Only patients with nontuberculous mycobacterial infections without HIV infection will be considered for long-term disease management. INCLUSION CRITERIA FOR RELATIVES: As part of this protocol, we may obtain medical records, blood work, urine, saliva or buccal swab from some blood relatives of patients on the study, with the hope of isolating and characterizing the primary immune defect(s) responsible for mycobacterial infection susceptibilityand 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. Male and female patients will be accepted without limitation due to age. These relatives will not receive treatment or have any other protocol procedures done unless they become a patient on the study. EXCLUSION CRITERIA: None.
Where this trial is running
Bethesda, Maryland
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.