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.
| Status | Terminated |
| Enrollment | 20 |
| Est. completion date | April 2014 |
| Est. primary completion date | April 2014 |
| Accepts healthy volunteers | No |
| Gender | Both |
| Age group | 3 Months to 18 Years |
| Eligibility |
Inclusion Criteria: 1. Any febrile episode in : - either a neutropenic child suffering from acute lymphoblastic leukemia under induction chemotherapy or relapse, acute myeloblastic leukemia under chemotherapy (all cycles of chemotherapy included) or myelodysplasic syndrome - an allogenetic hematopoietic stem cell transplantation recipient child, from conditioning till 3 months or receiving aggressive immunosuppressive therapy for at least 1 months 2. Age of children will be from 3 months till 18 years 3. Informed consent from the parents and from children older than 12 years obtained Exclusion Criteria: 1. Any previous history of fungal infection (proven, probable or possible) with prescription of secondary oral prophylaxis (voriconazole or posaconazole) under current use at the time of the study. 2. Any previous episode already enrolled (only one episode/patient). |
Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
| Country | Name | City | State |
|---|---|---|---|
| n/a | |||
| Lead Sponsor | Collaborator |
|---|---|
| Queen Fabiola Children's University Hospital | Merck Sharp & Dohme Corp. |
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | 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 | No |
| Secondary | % of early diagnosis of invasive fungal infection using serum 1,3 beta-D-glucan test | 1 year after the end of the study | No | |
| Secondary | 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 | No | |
| Secondary | incidence of invasive fungal infection among neutropenic febrile episodes reported | 1 year after the end of the study | No |