Analysis T Cells Response for Identification of Aspergillus Bronchitis With Cystic Fibrosis Patients

• Sponsor: University Hospital, Montpellier (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02550041
• Collaborator: (none)
• Enrollment: 68
• Location: 1
• Arm: 1
• Actual Duration (Months): 20.8
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cystic Fibrosis Patient; Patient Without Treatment Against A.Fumigatus	Other: T specific response for diagnostic of aspergillus bronchitis	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 68 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Actual Study Start Date: Sep 7, 2015
• Actual Primary Completion Date: Sep 7, 2016
• Actual Study Completion Date: Jun 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Other: Cystic fibrosis	Other: T specific response for diagnostic of aspergillus bronchitis

Outcome Measures

Primary Outcome Measures

1. 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

2. Cytokine level of TCD8 [12 months]

   Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis

3. Cytokine level CD4 cells [12 months]

   Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis

Secondary Outcome Measures

1. Level of fumigatus specific IgE [12 months]

   Contribution of several biological tests improve classification of aspergillus bronchitis

2. Level of fumigatus specific IgG [12 months]

   Contribution of several biological tests improve classification of aspergillus bronchitis

3. Real-time PCR for aspergillus in sputum [12 months]

   Contribution of several biological tests improve classification of aspergillus bronchitis

4. Galactomannan by enzyme immune assay detection in sputum [12 months]

   Contribution of several biological tests improve classification of aspergillus bronchitis

5. Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry [12 months]

   Contribution of several biological tests improve classification of aspergillus bronchitis

6. 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

7. Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment [12 months]

8. 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

9. Elispot dedicated to anti-aspergillus CD4 T cell [12 months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 15 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Irmb/U1058	Montpellier		France	34000

Sponsors and Collaborators

• University Hospital, Montpellier

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Montpellier
• ClinicalTrials.gov Identifier: NCT02550041
• Other Study ID Numbers: UF 9582
• First Posted: Sep 15, 2015
• Last Update Posted: May 9, 2019
• Last Verified: Dec 1, 2016

• Keywords provided by University Hospital, Montpellier: Bronchitis aspergillus; cystic fibrosis
• Additional relevant MeSH terms: Bronchitis; Cystic Fibrosis; Fibrosis

Study Results

No Results Posted as of May 9, 2019