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

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
AgeNot listed
SponsorResearch Center Borstel

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.

Eligibility criteria

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

  • Multi-modal NTM diagnostic including PCR, WGS, culture

Treatment groups

120 Participants
are divided into 2 treatment groups

Sponsors and collaborators