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

May 7, 2019 updated by: University Hospital, Montpellier

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

68

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
      • Montpellier, France, 34000
        • Irmb/U1058

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

15 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of CD4 T cell response against Aspergillus fumigatus in patients with cystis fibrosis
Time Frame: 12 months
Analysis T cells response for identification of aspergillus bronchitis with cystic fibrosis patients
12 months
Cytokine level of TCD8
Time Frame: 12 months
Qualitative Evaluation of cytokine level (IFNg, TNFa, IL10 and IL4) of TCD8 to identify ABPA and aspergillus bronchitis
12 months
Cytokine level CD4 cells
Time Frame: 12 months
Qualitative Evaluation of cytokine level CD4 cells in order to identify ABPA and aspergillus bronchitis
12 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Level of fumigatus specific IgE
Time Frame: 12 months
Contribution of several biological tests improve classification of aspergillus bronchitis
12 months
Level of fumigatus specific IgG
Time Frame: 12 months
Contribution of several biological tests improve classification of aspergillus bronchitis
12 months
Real-time PCR for aspergillus in sputum
Time Frame: 12 months
Contribution of several biological tests improve classification of aspergillus bronchitis
12 months
Galactomannan by enzyme immune assay detection in sputum
Time Frame: 12 months
Contribution of several biological tests improve classification of aspergillus bronchitis
12 months
Levels of cytokine (IFNg, IL10, IL4 and TNF) evaluated by flow cytometry
Time Frame: 12 months
Contribution of several biological tests improve classification of aspergillus bronchitis
12 months
Level of IL10 evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Time Frame: 12 months
Contribution of several biological tests improve classification of aspergillus bronchitis
12 months
Flow cytometry techniques dedicated to anti-aspergillus CD4 T cell assessment
Time Frame: 12 months
12 months
Level of IFNg evaluated by Elispot dedicated to anti-aspergillus CD4 T cells
Time Frame: 12 months
Contribution of several biological tests improve classification of aspergillus bronchitis
12 months
Elispot dedicated to anti-aspergillus CD4 T cell
Time Frame: 12 months
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Montpellier

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 7, 2015

Primary Completion (Actual)

September 7, 2016

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

August 20, 2015

First Submitted That Met QC Criteria

September 11, 2015

First Posted (Estimate)

September 15, 2015

Study Record Updates

Last Update Posted (Actual)

May 9, 2019

Last Update Submitted That Met QC Criteria

May 7, 2019

Last Verified

December 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UF 9582

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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