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

NCT07369414 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 120

Last updated 2026-01-27

No results posted yet for this study

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.

Conditions

  • Cystic Fibrosis (CF)
  • Mucoviscidosis
  • Non-Tuberculous Mycobacteria
  • Mycobacterium Abscessus Infection

Interventions

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.

Sponsors & Collaborators

  • Research Center Borstel

    lead OTHER

Principal Investigators

  • Alexander Mischnik, Prof. Dr. med. · National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-31
Primary Completion
2028-12-31
Completion
2030-12-31

Countries

  • Germany

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07369414 on ClinicalTrials.gov