Cystic Fibrosis (CF)NTMecoCFNCT07369414
Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households
An observational study of Cystic Fibrosis (CF) and Mucoviscidosis, run by Research Center Borstel at 2 sites in Germany.
Trial 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). Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Cystic Fibrosis (CF), Mucoviscidosis, Non-Tuberculous Mycobacteria
- What is being tested?
- Multi-modal NTM diagnostic including PCR, WGS, culture
- How many people
- 120 participants
- Where
- 2 sitesGermany
- Study dates
- 16 Feb 2026to Dec 2030
- Phase
- Observational
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Lack of capacity to provide informed consent, refusal to participate, or withdrawal of informed consent
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Germany2 sites, 2 recruiting
- Recruiting
National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center
Borstel, Schleswig-Holstein, 23845
Margo Dirics, PhD, +49 4537 / 188-7540, mdiricks@fz-borstel.de
Niklas Koehler, Dr. med., +49 4537 188 8080, studienzentrum@fz-borstel.de
- Not yet recruiting
Klinik für Pneumologie, Universitätsklinikum Essen
Essen
Sivagurunathan Sutharsan, PD Dr. med., 0201 433-4001, Sivagurunathan.Sutharsan@rlk.uk-essen.de
Sivagurunathan Sutharsan, PD Dr. med.
About this study
Official title: Environmental Reservoirs of Non-tuberculous Mycobacteria in Cystic Fibrosis Households: A Case-control Study of Exposure Risk at Home
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.
Read the detailed description
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.
- Conditions
- Cystic Fibrosis (CF), Mucoviscidosis, Non-Tuberculous Mycobacteria, Mycobacterium Abscessus Infection
- Being tested
- Multi-modal NTM diagnostic including PCR, WGS, culture
- Keywords
- Environmental reservoirs, Household water systems, Microbial exposure, Whole-genome sequencing, Environmental risk factors
- Medical subject headings
- Cystic Fibrosis, Mycobacterium Infections, Nontuberculous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Case group | 60 CF patients with a confirmed current or previously diagnosed NTM infection (according to ATS/IDSA criteria) Receives: 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) Receives: Other: Multi-modal NTM diagnostic including PCR, WGS, culture |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 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.
Measured: December 2030
Secondary outcomes (3)
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).
Measured: 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.
Measured: 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.
Measured: December 2030
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2026
- Study start16 Feb 2026
- Primary completionDec 2028 (estimated)
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cystic Fibrosis (CF)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Research Center Borstel
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Alexander Mischnik, Research Center Borstel
- Investigators
- Alexander Mischnik, Prof. Dr. med., Principal investigator, National and WHO-Supranational Reference Center for Mycobacteria, Research Center Borstel, Leibniz Lung Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07369414
- Sponsor's protocol ID
- NTMecoCF
- Acronym
- NTMecoCF
- Status last verified
- Jan 2026
- First submitted
- 16 Jan 2026
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: IPD will be shared upon reasonable request via contacting the prinicpal investigator.