Household water and home environments as sources of non-tuberculous mycobacteria in people with cystic fibrosis
Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households: A Case-control Study of Exposure Risk at Home
This study will test whether household water, dust, and soil carry non-tuberculous mycobacteria that could infect people with cystic fibrosis.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 120 (estimated) |
| Sex | All |
| Sponsor | Research Center Borstel Academic / other |
| Locations | 2 sites (Borstel, Schleswig-Holstein and 1 other locations) |
| Trial ID | NCT07369414 on ClinicalTrials.gov |
What this trial studies
This multicenter case-control study will enroll about 120 people with cystic fibrosis in Germany, including roughly 60 with current or past pulmonary NTM infection and 60 without known NTM. Environmental samples (water, dust, and soil) will be collected from participants' homes and analyzed by culture, PCR, and whole-genome sequencing. Findings in case and control households will be compared and any environmental isolates will be genetically compared with available clinical isolates. Standardized questionnaires and up to three years of follow-up for new NTM infections will be used to link environmental and behavioral risk factors to infection risk, and no additional medical procedures are required.
Who should consider this trial
Good fit: Ideal candidates are people with confirmed cystic fibrosis (of any age) who can give informed consent, including about 60 with documented NTM per ATS/IDSA criteria and available clinical isolates and 60 without known NTM as controls.
Not a fit: People without cystic fibrosis, those unable to provide informed consent, or participants without available clinical isolates may not receive direct personal benefit since the study is observational.
Why it matters
Potential benefit: If successful, the results could help patients by identifying household sources of NTM and informing practical prevention guidance to reduce future infections.
How similar studies have performed: Previous studies using environmental sampling and whole-genome sequencing have sometimes found matching household and patient strains, but results have been variable and not definitive.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Confirmed diagnosis of cystic fibrosis (CF) * No age restriction (including minors with consent from legal guardians) * Written informed consent to participate in the study (or consent provided by a legal guardian for minors) * In the case of an NTM infection: diagnosis according to ATS/IDSA criteria and availability of a clinical NTM isolate Exclusion Criteria: * Lack of capacity to provide informed consent, refusal to participate, or withdrawal of informed consent
Where this trial is running
Borstel, Schleswig-Holstein and 1 other locations
- National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center — Borstel, Schleswig-Holstein, Germany (Recruiting)
- Klinik für Pneumologie, Universitätsklinikum Essen — Essen, Germany (Not_yet_recruiting)
Study contacts
- Principal investigator: Alexander Mischnik, Prof. Dr. med. — National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center
- Study coordinator: Margo Diricks, PhD
- Email: mdiricks@fz-borstel.de
- Phone: +49 4537 / 188-7540
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.