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

NCT ID: NCT02550041

Last Updated: 2019-05-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

NA

Total Enrollment

68 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-09-07

Study Completion Date

2017-06-30

Brief Summary

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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

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Conditions

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Cystic Fibrosis Patient Patient Without Treatment Against A.Fumigatus

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Cystic fibrosis

Group Type OTHER

T specific response for diagnostic of aspergillus bronchitis

Intervention Type OTHER

Interventions

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T specific response for diagnostic of aspergillus bronchitis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

15 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Hospital, Montpellier

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Irmb/U1058

Montpellier, , France

Site Status

Countries

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France

Other Identifiers

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UF 9582

Identifier Type: -

Identifier Source: org_study_id

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