Trials Sponsors Conditions Drugs Pricing

Conditions

Non-Tuberculous Mycobacterial Pneumonia

Keywords

Cystic FibrosisInterferon gamma release assayDiagnostic Test

Outcome Measures

Primary Outcomes (1)

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.
day 1 (V1)

Secondary Outcomes (1)

Evaluation of T lymphocyte response
day 1 (V1)

Study Arms (2)

Case group MNT +

Cystic fibrosis patients with positive serology and positive culture

Other: Scheduled visit (V1)

Control group MNT -

Cystic fibrosis patients with negative serology and negative culture

Other: Scheduled visit (V1)

Interventions

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.

Case group MNT +Control group MNT -

Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.

Eligibility Criteria

Age18 Years+

Sexall

Healthy VolunteersNo

Age GroupsAdult (18-64), Older Adult (65+)

Sampling MethodNon-Probability Sample

Study Population

Adult patients with cystic fibrosis included in the CIMeNT study (N°ID RCB : 2017-A00025-48)

You may qualify if:

Patient ≥18 years

Sponsors & Collaborators

Hôpital Cochin
Othercollaborator
Cystic Fibrosis Foundation
Othercollaborator
University Hospital, Montpellier

Study Sites (1)

CHU de Montpellier - Hôpital Arnaud de Villeneuve

Montpellier, France

RECRUITING

Rapheal CHIRON, Hospital PraticienCONTACT00334.67.33.61.15 r.chiron@chu-montpelier.fr

MeSH Terms

Conditions

Cystic Fibrosis

Interventions

myotrophin

Condition Hierarchy (Ancestors)

Pancreatic DiseasesDigestive System DiseasesLung DiseasesRespiratory Tract DiseasesGenetic Diseases, InbornCongenital, Hereditary, and Neonatal Diseases and AbnormalitiesInfant, Newborn, Diseases

Study Officials

Raphael CHIRON, MD
Hôpital Arnaud de Villeneuve
PRINCIPAL INVESTIGATOR

Central Study Contacts

Raphael CHIRON, MD

CONTACT

0467336115 r-chiron@chu-montpellier.fr

Jean-Louis HERRMANN, Pr

CONTACT

0147104470

Study Design

Study Type: observational
Observational Model: CASE CONTROL
Time Perspective: CROSS SECTIONAL
Sponsor Type: OTHER
Responsible Party: SPONSOR

Study Record Dates

First Submitted

September 16, 2024

First Posted

September 19, 2024

Study Start

September 17, 2024

Actual (reported)

Primary Completion

August 1, 2026

Estimated (date passed)

This estimate has passed. The registry has not confirmed an actual date for this milestone.

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

Brief Summary

Registry Overview

Trial Relationships

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Case group MNT +

Control group MNT -

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations

Brief Summary

Registry Overview

Trial Relationships

Related Scientific Literature

Study Timeline

First Submitted

Study Start

First Posted

Primary Completion

Study Completion

Conditions

Keywords

Outcome Measures

Primary Outcomes (1)

Secondary Outcomes (1)

Study Arms (2)

Case group MNT +

Control group MNT -

Interventions

Eligibility Criteria

You may qualify if:

Sponsors & Collaborators

Study Sites (1)

MeSH Terms

Conditions

Interventions

Condition Hierarchy (Ancestors)

Study Officials

Central Study Contacts

Study Design

Study Record Dates

You may not qualify if:

Source record

Locations