Status:
UNKNOWN
iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients
Lead Sponsor:
Pathoquest
Conditions:
Febrile Neutropenia
Acute Leukemia
Eligibility:
All Genders
5+ years
Brief Summary
Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropen...
Detailed Description
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...
Eligibility Criteria
Inclusion
- 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).
Exclusion
- 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
Key Trial Info
Start Date :
May 18 2018
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
May 31 2019
Estimated Enrollment :
97 Patients enrolled
Trial Details
Trial ID
NCT03364257
Start Date
May 18 2018
End Date
May 31 2019
Last Update
March 21 2019
Active Locations (5)
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1
Hospital Necker
Paris, France
2
Hospital Robert Debré
Paris, France
3
Hospital Salpétrière
Paris, France
4
Hospital Trousseau
Paris, France