New Biomarkers for Invasive Fungal Infections in Paediatric Haemato-oncology

NCT ID: NCT02587377

Last Updated: 2015-10-27

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-06-30
• Study Completion Date: 2014-04-30

Brief Summary

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.

Conditions

Haemato-oncological Paediatric Patients Under Intensive Chemotherapy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Cohort 1

single cohort of patient

Group Type: OTHER

Non Standard of Care blood samples collection

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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).

• Minimum Eligible Age: 3 Months
• Maximum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

Queen Fabiola Children's University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Other Identifiers

HU14

Identifier Type: -

Identifier Source: org_study_id