NCT07369414

Brief 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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
120

participants targeted

Target at P50-P75 for all trials

Timeline
56mo left

Started Jan 2026

Longer than P75 for all trials

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress7%
Jan 2026Dec 2030

Study Start

First participant enrolled

January 1, 2026

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

January 16, 2026

Completed
11 days until next milestone

First Posted

Study publicly available on registry

January 27, 2026

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2028

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2030

Last Updated

January 27, 2026

Status Verified

January 1, 2026

Enrollment Period

2.9 years

First QC Date

January 16, 2026

Last Update Submit

January 16, 2026

Conditions

Mycobacterium Abscessus InfectionCystic Fibrosis (CF)MucoviscidosisNon-Tuberculous Mycobacteria

Keywords

Environmental reservoirsHousehold water systemsMicrobial exposureWhole-genome sequencingEnvironmental risk factors

Outcome Measures

Primary Outcomes (3)

  • 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).

    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.

    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.

    2030

Secondary Outcomes (3)

  • Characterization of NTM species from environmental samples

    2030

  • Identification of environmental and behavioral factors associated with NTM detection

    2030

  • Long-term outcomes (control group only)

    2030

Study Arms (2)

Case group

60 CF patients with a confirmed current or previously diagnosed NTM infection (according to ATS/IDSA criteria)

Other: Multi-modal NTM diagnostic including PCR, WGS, culture

Control group

60 CF patients without a known or previously diagnosed NTM infection (according to ATS/IDSA criteria)

Other: Multi-modal NTM diagnostic including PCR, WGS, culture

Interventions

Multi-modal NTM diagnostic including PCR, WGS, cultureOTHER

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.

Case groupControl group

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

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.

You may qualify if:

  • 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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center

Borstel, Schleswig-Holstein, 23845, Germany

RECRUITING

Klinik für Pneumologie, Universitätsklinikum Essen

Essen, Germany

NOT YET RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

Mycobacterial strains

MeSH Terms

Conditions

Cystic FibrosisMycobacterium Infections, Nontuberculous

Interventions

Whole Genome SequencingCulture Techniques

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, DiseasesMycobacterium InfectionsActinomycetales InfectionsGram-Positive Bacterial InfectionsBacterial InfectionsBacterial Infections and MycosesInfections

Intervention Hierarchy (Ancestors)

Sequence Analysis, DNASequence AnalysisGenetic TechniquesInvestigative TechniquesIn Vitro Techniques

Study Officials

  • Alexander Mischnik, Prof. Dr. med.

    National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Margo Diricks, PhD

CONTACT

+49 4537 / 188-7540mdiricks@fz-borstel.de

Niklas Koehler, Dr. med.

CONTACT

+49 4537 188 8080studienzentrum@fz-borstel.de

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. med. Alexander Mischnik

Study Record Dates

First Submitted

January 16, 2026

First Posted

January 27, 2026

Study Start

January 1, 2026

Primary Completion (Estimated)

December 1, 2028

Study Completion (Estimated)

December 1, 2030

Last Updated

January 27, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

IPD will be shared upon reasonable request via contacting the prinicpal investigator.

Locations

DE(2)