Haemato-oncological Paediatric Patients Under Intensive Chemotherapy Clinical Trial
Official title:
New Biomarkers for Invasive Fungal Infections in Paediatric Haemato-oncology. A National Belgian Study
The availability of sensitive and specific fungal biomarkers could be a precious help to
improve the management of patients suffering from fungal diseases, not only by allowing
preemptive treatment, but also by offering objective elements to assess patient therapeutic
response and prognosis.
The use of such biomarkers could also contribute to accurately evaluate novel antifungal
drugs effectiveness and to serve as a valuable tool to guide decisions regarding ineffective
treatments and dose selection in product development. Using two or three tests may increase
the sensitivity to detect IFI.
The results of the serum assays will be correlated to the definition of 'proven' fungal
infection as defined by the EORTC/MSG criteria published in 2008. Based upon results from
adults' studies, the investigators estimate that galactomannan antigen or 1, 3 β-D glucan
could reasonably have a 90% sensitivity (with a 95% CI between 73% and 98%) under the
current design. As concern the aspergillus fumigatus PCR, sensitivity and specificity could
be estimated between 63% to 100% and 87% to 96.7%, respectively.
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Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic