Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients
- Conditions
- Cystic Fibrosis PatientPatient Without Treatment Against A.Fumigatus
- Interventions
- Other: T specific response for diagnostic of aspergillus bronchitis
- Registration Number
- NCT02550041
- Lead Sponsor
- University Hospital, Montpellier
- Brief Summary
The study aims to asses the ability of cell tests based on the analysis of the anti-Aspergillus cell responses and identify Aspergillus bronchitis with patients with cystic fibrosis.
In addition, the study will evaluate the contribution of biological classification of aspergillosis according to criteria recently proposed by Baxter et al. compared to the classification used in clinical practice in the hospital of Montpellier.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 68
- Patient with cystic fibrosis followed at Resource Centers and Cystic Fibrosis Skills (CRCM) Montpellier
- Patient aged 15 or over
- Patient able to understand the nature, purpose and methodology of the study.
- Patient and his legal representative for minors who have given their free and informed consent
- Affiliate or beneficiary of a social security scheme.
- Patients on antifungal treatment at the time of sampling
- Pregnant or breastfeeding
- Major protected by law (guardianship, curator or under Backup Justice)
- Inability to understand the nature and goals of the study and / or communication difficulties with the investigator
- Subject attending another search including a period of exclusion still going to run-in
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Cystic fibrosis T specific response for diagnostic of aspergillus bronchitis -
- Primary Outcome Measures
Name Time Method Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis 12 months Analysis T cells response for identification of aspergillus bronchitis with cystic fibrosis patients
Cytokine level CD4 cells 12 months Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis
Cytokine level of TCD8 12 months Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis
- Secondary Outcome Measures
Name Time Method Level of fumigatus specific IgE 12 months Contribution of several biological tests improve classification of aspergillus bronchitis
Level of fumigatus specific IgG 12 months Contribution of several biological tests improve classification of aspergillus bronchitis
Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells 12 months Contribution of several biological tests improve classification of aspergillus bronchitis
Real-time PCR for aspergillus in sputum 12 months Contribution of several biological tests improve classification of aspergillus bronchitis
Galactomannan by enzyme immune assay detection in sputum 12 months Contribution of several biological tests improve classification of aspergillus bronchitis
Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry 12 months Contribution of several biological tests improve classification of aspergillus bronchitis
Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells 12 months Contribution of several biological tests improve classification of aspergillus bronchitis
Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment 12 months Elispot dedicated to anti-aspergillus CD4 T cell 12 months
Trial Locations
- Locations (1)
Irmb/U1058
🇫🇷Montpellier, France