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.
This multicenter, non-interventional case-control study investigates whether domestic environmental reservoirs-particularly household water systems-contribute to non-tuberculous mycobacterial (NTM) infections in people with cystic fibrosis (CF). Approximately 120 CF patients from several centers in Germany will be enrolled, including 60 patients with a current or previous pulmonary NTM infection and 60 CF patients without known NTM infection as controls. Environmental samples (water, dust, and soil) will be collected from participants' households and analyzed for the presence of NTM using culture-based methods, PCR, and whole-genome sequencing. These findings will be compared between case and control households, and genetic similarity between environmental NTM isolates and available clinical isolates from the same patients will be assessed. In addition, standardized questionnaires will capture environmental and behavioral risk factors associated with NTM occurrence. The study is purely observational and relies on clinical data and isolates obtained through routine CF care, with no additional medical procedures for participants. Over a follow-up period of up to three years, newly occurring NTM infections in initially unaffected patients will be documented. The results aim to improve understanding of environmental exposure risks for NTM in CF and to provide evidence for future prevention strategies and potential guideline recommendations.
Study Type
OBSERVATIONAL
Enrollment
120
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.
National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, Germany
RECRUITINGKlinik für Pneumologie, Universitätsklinikum Essen
Essen, Germany
NOT_YET_RECRUITINGPrevalence of NTM in environmental samples
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).
Time frame: December 2030
Difference in NTM prevalence between case and control groups
Statistically significant difference in the frequency of NTM detection (clinically relevant and/or all NTM) in environmental samples between case group and control group.
Time frame: December 2030
Genetic concordance between environmental and patient isolates
Evidence of genetic relatedness (e.g., cgMLST clustering) between NTM detected in the household environment and clinical isolates from the same individual.
Time frame: December 2030
Characterization of NTM species from environmental samples
Identification and taxonomic classification of NTM isolates using WGS, including typing (e.g., subspecies assignment for M. avium).
Time frame: December 2030
Identification of environmental and behavioral factors associated with NTM detection
Determination of significant risk factors (e.g., use of specific water sources, pet ownership, hygiene practices) based on questionnaire data and multivariable analyses.
Time frame: December 2030
Long-term outcomes (control group only)
Proportion of patients without an initial NTM infection who develop a clinically relevant NTM infection during the follow-up period (up to 30 months), potentially in association with prior detection of NTM in the household environment.
Time frame: December 2030
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