Invasive Fungal Infections Clinical Trial
— BETA GLUCANOfficial 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.
| NCT number | NCT02851680 |
| Other study ID # | DALLE 2013 |
| Secondary ID | |
| Status | Completed |
| Phase | N/A |
| First received | July 28, 2016 |
| Last updated | August 2, 2016 |
| Start date | September 2014 |
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.
| Status | Completed |
| Enrollment | 476 |
| Est. completion date | |
| Est. primary completion date | May 2015 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
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) |
Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Dijon Bourgogne | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
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