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New Biomarkers for Invasive Fungal Infections in Paediatric Haemato-oncology

NCT02587377 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 20

Last updated 2015-10-27

No results posted yet for this study

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

Interventions

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.

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Months
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2013-06-30
Primary Completion
2014-04-30
Completion
2014-04-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02587377 on ClinicalTrials.gov