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

Sponsor

Centre Hospitalier Universitaire Dijon (Other)

Overall Status

Completed

CT.gov ID

NCT02851680

Collaborator

(none)

476

Enrollment

Location

Arms

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Invasive Fungal Infections	Biological: blood samples	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

476 participants

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Official Title:

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

Study Start Date :

Sep 1, 2014

Actual Primary Completion Date :

May 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Fongitell test	Biological: blood samples
Active Comparator: serum galactomannan	Biological: blood samples

Arm

Intervention/Treatment

Experimental: Fongitell test

Biological: blood samples

Active Comparator: serum galactomannan

Biological: blood samples

Outcome Measures

Primary Outcome Measures

Comparison of the results of the 1-3 ß D glucan serum assay obtained with the Fungitell® test and the test currently used (in terms of specificity, sensitivity, negative predictive value and positive predictive value [8 to 10 assays over 4 to 5 weeks of hospitalization]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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)

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	CHU Dijon Bourgogne	Dijon		France	21079

Sponsors and Collaborators

Centre Hospitalier Universitaire Dijon

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Centre Hospitalier Universitaire Dijon

ClinicalTrials.gov Identifier:

NCT02851680

Other Study ID Numbers:

DALLE 2013

First Posted:

Aug 2, 2016

Last Update Posted:

Aug 3, 2016

Last Verified:

Jun 1, 2016

Additional relevant MeSH terms:

Mycoses

Aspergillosis

Invasive Fungal Infections

Study Results

No Results Posted as of Aug 3, 2016