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

Not Applicable
Completed
Conditions
Invasive Fungal Infections
Interventions
Biological: blood samples
Registration Number
NCT02851680
Lead Sponsor
Centre Hospitalier Universitaire Dijon
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.

Detailed Description

Not available

Recruitment & Eligibility

Status
COMPLETED
Sex
Female
Target Recruitment
476
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)

Study & Design

Study Type
INTERVENTIONAL
Study Design
PARALLEL
Arm && Interventions
GroupInterventionDescription
Fongitell testblood samples-
serum galactomannanblood samples-
Primary Outcome Measures
NameTimeMethod
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 value8 to 10 assays over 4 to 5 weeks of hospitalization
Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (1)

CHU Dijon Bourgogne

🇫🇷

Dijon, France

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