An interventional study of Non Standard of Care blood samples collection in Haemato-oncological Paediatric Patients Under Intensive Chemotherapy, sponsored by Queen Fabiola Children's University Hospital. Terminated. Open to participants aged 3 Months to 18 Years. Per ClinicalTrials.gov, last updated 2015-10-27.
Sponsored by Queen Fabiola Children's University Hospital · Not applicable, Interventional, and Diagnostic
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.
539 studies on the registry are indexed under Mycoses; 55 are open to participants now.
This study's enrollment of 20 is below the median of 46 across 358 interventional studies indexed under Mycoses.
Browse Mycoses studies →Queen Fabiola Children's University Hospital is the lead sponsor of 28 studies on the registry; 6 are open to participants now.
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Any febrile episode in :
Exclusion Criteria:
single cohort of patient
Other: Non Standard of Care blood samples collection
According to Belgian Law of 07MAY2004, if non standard of care interventions are performed as per protocol, the study must be classified as Interventional Study.
clinical relevance of a "combined tests strategy" (positive results of serum 1,3 beta-D-glucan test and/or PCR Aspergillus fumigatus, with or without positive galactomannan antigen) to improve early diagnosis of IFI
To assess the clinical relevance, in term of sensitivity and specificity, of a "combined tests strategy" (positive results of serum 1,3 beta-D-glucan test and/or PCR Aspergillus fumigatus, with or without positive galactomannan antigen) to improve early diagnosis of IFI and to allow a pre-emptive "diagnostic driven" therapeutic approach among haemato-oncological immunocompromised children.
Time frame: 1 year after the end of the study
% of early diagnosis of invasive fungal infection using serum 1,3 beta-D-glucan test
Time frame: 1 year after the end of the study
Validity of the PCR for A. fumigatus in early diagnosis of invasive aspergillosis in a pediatric population.
Time frame: 1 year after the end of the study
incidence of invasive fungal infection among neutropenic febrile episodes reported
Time frame: 1 year after the end of the study
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Queen Fabiola Children's University Hospital