NCT07369414|Recruiting
Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households
NTMecoCF
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NTMecoCF
Sponsor study identifier
observational
120
1 country
2
Study Start
February 16, 2026
Actual (reported)Primary Completion
December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 16, 2026
Actual (reported)January 27, 2026
Actual (reported)February 16, 2026
Actual (reported)December 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Prevalence 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).
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.
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.
60 CF patients with a confirmed current or previously diagnosed NTM infection (according to ATS/IDSA criteria)
60 CF patients without a known or previously diagnosed NTM infection (according to ATS/IDSA criteria)
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
The study population comprises 120 individuals with a confirmed diagnosis of cystic fibrosis recruited from multiple centers in Germany. Participants include both adults and minors (with consent from legal guardians) and are divided equally into a case group of patients with a current or prior pulmonary NTM infection and a control group of patients without a known history of NTM infection. All participants provide written informed consent, and clinical data and isolates are obtained exclusively from routine care.
National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, 23845, Germany
Klinik für Pneumologie, Universitätsklinikum Essen
Mycobacterial strains
Alexander Mischnik, Prof. Dr. med.
National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center
First Submitted
January 16, 2026
First Posted
January 27, 2026
Study Start
February 16, 2026
Actual (reported)Primary Completion
December 2028
EstimatedDecember 2030
Characterization of NTM species from environmental samples
December 2030
Identification of environmental and behavioral factors associated with NTM detection
December 2030
Long-term outcomes (control group only)
December 2030
Contact the study team to confirm eligibility.
Essen, Germany
Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 2030
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
August 19, 2026
Record last verified: 2026-01
IPD will be shared upon reasonable request via contacting the prinicpal investigator.
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Source: ClinicalTrials.gov.
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