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RECRUITINGOBSERVATIONAL

Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households: A Case-control Study of Exposure Risk at Home

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

This multicenter, non-interventional case-control study investigates whether household environmental reservoirs, particularly water systems, are associated with non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis. Environmental samples from the homes of CF patients with and without NTM infection will be analyzed and genetically compared with available clinical isolates, alongside assessment of environmental risk factors, to improve understanding of exposure pathways and inform future prevention strategies.

Who May Be Eligible (Plain English)

Who May Qualify: - Confirmed diagnosis of cystic fibrosis (CF) - No age restriction (including minors with consent from legal guardians) - Written willing to sign a consent form 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 Who Should NOT Join This Trial: - Lack of capacity to provide willing to sign a consent form, refusal to participate, or withdrawal of willing to sign a consent form Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

OTHER

Multi-modal NTM diagnostic including PCR, WGS, culture

Environmental samples from participants' households (e.g., water, dust, and soil) will be collected and tested for the presence of NTM. Analyses will be performed using PCR, culture-based methods, whole-genome sequencing (WGS), and subsequent bioinformatic analyses. In addition, available clinical NTM isolates from previous or future routine diagnostics will be included. If genomic sequencing has not yet been performed for these isolates, retrospective molecular genetic analysis (e.g., by WGS) will be conducted within the study to enable comparison with environmental isolates.

Locations (2)

National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, Germany
Klinik für Pneumologie, Universitätsklinikum Essen
Essen, Germany