Cystic Fibrosis Patient, Patient Without Treatment Against A.Fumigatus
Conditions
Keywords
Bronchitis aspergillus, cystic fibrosis
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.
Interventions
OTHERT specific response for diagnostic of aspergillus bronchitis
Sponsors
University Hospital, Montpellier
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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 of TCD8 | 12 months | Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis |
| Cytokine level CD4 cells | 12 months | Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Level of fumigatus specific IgE | 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 |
| Elispot dedicated to anti-aspergillus CD4 T cell | 12 months | — |
| Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment | 12 months | — |
| Level of fumigatus specific IgG | 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 |
Countries
France
Outcome results
None listed