Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households

Condition(s) studied

Investigational drug(s) / intervention(s)

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.

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 (CF). 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

Primary outcome measure(s)

• Prevalence of NTM in environmental samples — December 2030
  Proportion of households of CF patients with and without NTM infection in which at least one (clinically relevant) NTM is detected in environmental samples (water, dust, soil).
• Difference in NTM prevalence between case and control groups — December 2030
  Statistically significant difference in the frequency of NTM detection (clinically relevant and/or all NTM) in environmental samples between case group and control group.
• Genetic concordance between environmental and patient isolates — December 2030
  Evidence of genetic relatedness (e.g., cgMLST clustering) between NTM detected in the household environment and clinical isolates from the same individual.

Trial sites (2)

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