RecruitingNCT07369414

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

Sponsor

Research Center Borstel

Enrollment

120 participants

Start Date

Jan 1, 2026

Study Type

OBSERVATIONAL

Conditions

Cystic Fibrosis (CF)Mucoviscidosis

Summary

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.

Eligibility

Inclusion Criteria4

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 Criteria1

Lack of capacity to provide informed consent, refusal to participate, or withdrawal of informed consent

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Interventions

OTHERMulti-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.