Non-Tuberculous Mycobacterial PneumoniaMUCEMNCT06602869
Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis
An observational study of Non-Tuberculous Mycobacterial Pneumonia, run by University Hospital, Montpellier at 1 site in France.
Trial summary
This study evaluates a diagnostic serological test for Non-Tuberculous Mycobacteria (NTM) infection in cystic fibrosis patients by measuring T cell response. It aims to highlight a dynamic response associated to the pathogen's presence. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Non-Tuberculous Mycobacterial Pneumonia
- What is being tested?
- Scheduled visit (V1)
- How many people
- 76 participants
- Where
- 1 siteFrance
- Study dates
- 17 Sep 2024to 17 Sep 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult patients with cystic fibrosis included in the CIMeNT study (N°ID RCB : 2017-A00025-48)
Who may be able to join
- Patient ≥18 years
- Patient previously included in the CIMeNT study
- Patient with a confirmed diagnosis of cystic fibrosis regardless of CFTR genotype
- Patient affiliated to the social security system
- Patient registered in the French Cystic Fibrosis Registry
- Adult patient capable of spontaneous expectoration or after induction
Who cannot join
- Lung transplant patients
- Person placed under judicial protection
- Pregnant and breastfeeding women
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
CHU de Montpellier - Hôpital Arnaud de Villeneuve
Montpellier
Rapheal CHIRON, Hospital Praticien, 00334.67.33.61.15, r.chiron@chu-montpelier.fr
About this study
Official title: Cellular Markers During a Non-tuberculous Mycobacterial Respiratory Infection, Treated or Untreated, in Patients With Cystic Fibrosis
This study evaluates a diagnostic serological test for Non-Tuberculous Mycobacteria (NTM) infection in cystic fibrosis patients by measuring T cell response. It aims to highlight a dynamic response associated to the pathogen's presence. This multicenter case-control study involves two populations, providing a better understanding of the circulating T-IFNγ-MNT response in these patients.
Read the detailed description
Background: Evidence shows that Non-tuberculous Mycobacterial (NTM) infections have increased and are 1,000 to 8,000 times more frequent in patients with cystic fibrosis compared to the general population. The diagnosis is based on clinical, radiological, and microbiological criteria. Unfortunately, the first two criteria lack specificity, and microbiological detection of NTM is limited due to frequent sputum contamination by other pathogens in cystic fibrosis patients. Given these factors and the high incidence of NTM infections in this population, alternative diagnostic methods are necessary.
Aim: This study aims to validate an innovative diagnostic test based on the IGRA (Interferon-Gamma Release Assay) method, which measures T lymphocyte response to Interferon gamma (IFNγ). The test will be conducted on a subset of patients selected from the CIMeNT cohort (ID-RCB: 2017-A00025-48). This cohort consists of cystic fibrosis patients whose NTM infection prevalence has been previously assessed.
Method: This research is a multicenter case-control study. It includes two groups: a case group of patients with positive serological and/or microbiological responses indicating NTM infection, and a control group of patients without such responses. The test measures the host's immune response by evaluating circulating T cell activity. Specifically, it measures IFNγ release when T cells are in contact with NTM antigens. This method provides more informative diagnostics of NTM infection dynamics compared to serology or microbiology, which have known technical limitations.
The study involves a single visit, which is part of the routine care for cystic fibrosis patients. During this visit, a routine blood draw will be performed and an additional 7 ml tube will be collected.
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia
- Being tested
- Scheduled visit (V1)
- Keywords
- Cystic Fibrosis, Interferon gamma release assay, Diagnostic Test
- Medical subject headings
- Cystic Fibrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scheduled visit (V1)Other
During the scheduled visit (V1), as part of routine care, a blood draw will be performed. On this occasion, an additional 7 ml tube will be collected to perform serology and culture. This will help define the group (NTM+ Cases/NTM- Controls) and measure cellular biomarkers.
| Study group | Role | What they receive |
|---|---|---|
| Case group MNT + | Cystic fibrosis patients with positive serology and positive culture Receives: Other: Scheduled visit (V1) | |
| Control group MNT - | Cystic fibrosis patients with negative serology and negative culture Receives: Other: Scheduled visit (V1) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Determination of interferon-gamma release assay
Evaluation of T lymphocyte activation following mycobacterial antigen stimulation. The level of interferon gamma (IFN-γ) released is the measured marker of this activation, quantified in IU/ml. Sensitivity and specificity pairs will be calculated for each threshold value of the IFNγ rate in the T cell response test.
A Receiver Operating Characteristic (ROC) curve will be plotted with its Area Under the Curve (AUC) and 95% confidence interval. For each threshold, sensitivity and specificity values will be computed, along with their 95% confidence intervals.
The assessment aims to diagnose NTM in patients, as confirmed by serology and/or positive culture.
Measured: day 1 (V1)
Secondary outcomes (1)
Evaluation of T lymphocyte response
Measurement of IFN-γ release in response to T cell contact with NTM antigens, compared to clinical and radiological progression.
Measured: day 1 (V1)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study start17 Sep 2024
- Primary completion1 Aug 2026 (estimated)
- Study completion17 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non-Tuberculous Mycobacterial PneumoniaStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Cross-sectional
- Enrolment
- 76 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Collaborators
- Hôpital Cochin, Cystic Fibrosis Foundation
- Responsible party
- Sponsor
- Investigators
- Raphael CHIRON, MD, Principal investigator, Hôpital Arnaud de Villeneuve
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602869
- Sponsor's protocol ID
- RECHMPL24_0124
- Acronym
- MUCEM
- Status last verified
- Jul 2025
- First submitted
- 16 Sep 2024
- Last updated
- 10 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cellular Markers During a Non-tuberculous Mycobacterial Respiratory Infection, Treated or Untreated, in Patients With Cystic Fibrosis
- ClinicalTrials.gov ID
- NCT06602869
- Acronym / sponsor ID
- MUCEM / RECHMPL24_0124
- Conditions
- Non-Tuberculous Mycobacterial Pneumonia
- Keywords
- Cystic Fibrosis, Interferon gamma release assay, Diagnostic Test
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 76 participants (estimated)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Collaborators
- Hôpital Cochin, Cystic Fibrosis Foundation
- Study start
- 17 Sep 2024 (actual)
- Primary completion
- 1 Aug 2026 (estimated)
- Study completion
- 17 Sep 2026 (estimated)
- First posted
- 19 Sep 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates a diagnostic serological test for Non-Tuberculous Mycobacteria (NTM) infection in cystic fibrosis patients by measuring T cell response. It aims to highlight a dynamic response associated to the pathogen's presence. This multicenter case-control study involves two populations, providing a better understanding of the circulating T-IFNγ-MNT response in these patients.
Detailed description
Background: Evidence shows that Non-tuberculous Mycobacterial (NTM) infections have increased and are 1,000 to 8,000 times more frequent in patients with cystic fibrosis compared to the general population. The diagnosis is based on clinical, radiological, and microbiological criteria. Unfortunately, the first two criteria lack specificity, and microbiological detection of NTM is limited due to frequent sputum contamination by other pathogens in cystic fibrosis patients. Given these factors and the high incidence of NTM infections in this population, alternative diagnostic methods are necessary.
Aim: This study aims to validate an innovative diagnostic test based on the IGRA (Interferon-Gamma Release Assay) method, which measures T lymphocyte response to Interferon gamma (IFNγ). The test will be conducted on a subset of patients selected from the CIMeNT cohort (ID-RCB: 2017-A00025-48). This cohort consists of cystic fibrosis patients whose NTM infection prevalence has been previously assessed.
Method: This research is a multicenter case-control study. It includes two groups: a case group of patients with positive serological and/or microbiological responses indicating NTM infection, and a control group of patients without such responses. The test measures the host's immune response by evaluating circulating T cell activity. Specifically, it measures IFNγ release when T cells are in contact with NTM antigens. This method provides more informative diagnostics of NTM infection dynamics compared to serology or microbiology, which have known technical limitations.
The study involves a single visit, which is part of the routine care for cystic fibrosis patients. During this visit, a routine blood draw will be performed and an additional 7 ml tube will be collected.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Case group MNT + | – | Other: Scheduled visit (V1)Cystic fibrosis patients with positive serology and positive culture |
| Control group MNT - | – | Other: Scheduled visit (V1)Cystic fibrosis patients with negative serology and negative culture |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult patients with cystic fibrosis included in the CIMeNT study (N°ID RCB : 2017-A00025-48)
Key inclusion criteria (6 listed)
- Patient ≥18 years
- Patient previously included in the CIMeNT study
- Patient with a confirmed diagnosis of cystic fibrosis regardless of CFTR genotype
- Patient affiliated to the social security system
- Patient registered in the French Cystic Fibrosis Registry
Key exclusion criteria (3 listed)
- Lung transplant patients
- Person placed under judicial protection
- Pregnant and breastfeeding women
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scheduled visit (V1)During the scheduled visit (V1), as part of routine care, a blood draw will be performed. On this occasion, an additional 7 ml tube will be collected to perform serology and culture. This will help define the group (NTM+ Cases/NTM- Controls) and measure cellular biomarkers. | Other | Case group MNT +, Control group MNT - |
Primary outcome
Determination of interferon-gamma release assay
Time frame: day 1 (V1)
Evaluation of T lymphocyte activation following mycobacterial antigen stimulation. The level of interferon gamma (IFN-γ) released is the measured marker of this activation, quantified in IU/ml. Sensitivity and specificity pairs will be calculated for each threshold value of the IFNγ rate in the T cell response test. A Receiver Operating Characteristic (ROC) curve will be plotted with its Area Under the Curve (AUC) and 95% confidence interval. For each threshold, sensitivity and specificity values will be computed, along with their 95% confidence intervals. The assessment aims to diagnose NTM in patients, as confirmed by serology and/or positive culture.
1 secondary outcome
Evaluation of T lymphocyte response
Time frame: day 1 (V1)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Raphael CHIRON, MD principal investigator
Hôpital Arnaud de Villeneuve
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Non-Tuberculous Mycobacterial Pneumonia, run by University Hospital, Montpellier at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 10 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Raphael CHIRON, MD (0467336115, r-chiron@chu-montpellier.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determination of interferon-gamma release assay (time frame: day 1 (V1)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2025.