Interest of ß 1-3 D Glucan Assays in Screening for the Onset of Invasive Aspergillosis in Neutropenic Patients With Acute Leukaemia.

NCT ID: NCT02851680

Last Updated: 2016-08-03

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

COMPLETED

Clinical Phase

NA

Total Enrollment

476 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-30

Brief Summary

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In the context of screening for infectious fungal diseases in patients with malignant haemopathy, and particularly patients with acute leukaemia, the investigator aims to evaluate the performance of an already commercialized but little used serum screening test (Fungitell® test) and to determine its place in the management strategy for invasive aspergillosis.

Detailed Description

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Conditions

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Invasive Fungal Infections

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Blinding Strategy

NONE

Study Groups

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Fongitell test

Group Type EXPERIMENTAL

blood samples

Intervention Type BIOLOGICAL

serum galactomannan

Group Type ACTIVE_COMPARATOR

blood samples

Intervention Type BIOLOGICAL

Interventions

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blood samples

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* Patients who have been informed about the study
* Patients over 18 years
* patients with acute myeloblastic leukaemia (AML) or lymphoblastic leukaemia (ALL) who have undergone cytotoxic chemotherapy with curative intent

Exclusion Criteria

* Adults under guardianship
* Patients without national health insurance cover
* Pregnant or breast-feeding women
* allografts and autografts of Haematopoietic Stem Cells (HSC)
Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Centre Hospitalier Universitaire Dijon

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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CHU Dijon Bourgogne

Dijon, , France

Site Status

Countries

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France

Other Identifiers

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DALLE 2013

Identifier Type: -

Identifier Source: org_study_id

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