Cellular Markers in Treated or Untreated Non-tuberculous Mycobacterial Respiratory Infection in Patients With Cystic Fibrosis

NCT ID: NCT06602869

Last Updated: 2025-07-10

Basic Information

• Recruitment Status: RECRUITING
• Total Enrollment: 76 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-09-17
• Study Completion Date: 2026-09-17

Brief 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. 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.

Conditions

Non-Tuberculous Mycobacterial Pneumonia

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: CROSS_SECTIONAL

Study Groups

Case group MNT +

Cystic fibrosis patients with positive serology and positive culture

Scheduled visit (V1)

Intervention Type: 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.

Control group MNT -

Cystic fibrosis patients with negative serology and negative culture

Scheduled visit (V1)

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• 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

Exclusion Criteria

• Lung transplant patients
• Person placed under judicial protection
• Pregnant and breastfeeding women

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Hôpital Cochin

OTHER

Sponsor Role: collaborator

Cystic Fibrosis Foundation

OTHER

Sponsor Role: collaborator

University Hospital, Montpellier

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Raphael CHIRON, MD

Role: PRINCIPAL_INVESTIGATOR

Hôpital Arnaud de Villeneuve

Locations

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, , France

Site Status: RECRUITING

Countries

France

Central Contacts

Raphael CHIRON, MD

Role: CONTACT

r-chiron@chu-montpellier.fr

0467336115

Jean-Louis HERRMANN, Pr

Role: CONTACT

jean-louis.herrmann@aphp.fr

0147104470

Facility Contacts

Rapheal CHIRON, Hospital Praticien

Role: primary

r.chiron@chu-montpelier.fr

00334.67.33.61.15

Other Identifiers

RECHMPL24_0124

Identifier Type: -

Identifier Source: org_study_id