iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients (IDENTIFY)
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Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia
Febrile neutropenic patients suspected of sepsis will follow the conventional infectious diagnosis work-up over the entire observation period, and will be tested in addition with iDTECT Blood on Study Day 1.
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Layout table for eligibility information
Ages Eligible for Study:
5 Years and older (Child, Adult, Older Adult)
Sexes Eligible for Study:
Accepts Healthy Volunteers:
Patients treated with chemotherapy for Acute Leukaemia (AL) or Myelodysplastic Syndrome (MDS) or in the context of hematopoietic stem cell transplantation (HSCT), presenting a febrile neutropenic episode and suspected of infection
Age > 5 years and weight > 16 Kg
Patients having signed the written study informed consent form (ICF) prior to any study-mandated procedure. For children/adolescents: ICF obtained from both children's parents/ legal representative prior to any study-mandated procedure, and in addition for adolescents (13-17 years): assent form to be signed
Patient presenting severe neutropenia (absolute neutrophil count < 0.5 Giga/L) anticipated to be long lasting (> 10 days) following intensive chemotherapy for acute myeloid or lymphoid leukaemia (AML or ALL) or myelodysplastic syndrome or in the context of hematopoietic stem cells transplantation
Febrile episode (oral temperature > 38.3°C once, or 2 measures > 38.0°C taken 2h apart).
Known HIV infection or AIDS diagnosis
Already microbiologically confirmed infection
Patient status preventing the study test to be performed
Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation