Household water and home environments as sources of non-tuberculous mycobacteria in people with cystic fibrosis

Is this trial a fit for you?

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

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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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.