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The current rate of recruitment is insufficient.
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| Name | Class |
|---|---|
| Merck Sharp & Dohme LLC | INDUSTRY |
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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cohort 1 | Other | single cohort of patient |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Non Standard of Care blood samples collection | Other | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 1 year after the end of the study |
| Measure | Description | Time Frame |
|---|---|---|
| % of early diagnosis of invasive fungal infection using serum 1,3 beta-D-glucan test | 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. | 1 year after the end of the study |
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Inclusion Criteria:
Any febrile episode in :
Age of children will be from 3 months till 18 years
Informed consent from the parents and from children older than 12 years obtained
Exclusion Criteria:
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| incidence of invasive fungal infection among neutropenic febrile episodes reported | 1 year after the end of the study |