iDTECT Blood Performance for the Identification of Viral or Bacterial Pathogens in Febrile Neutropenic Patients

Study Overview
=================
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 neutropenia

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 Day 1.

Official Title
-----------------
National, Single-arm Clinical Study on iDTECT™ Blood Performance to Identify Viral or Bacterial Pathogens in Febrile Neutropenic Patients With Suspected Infection

Conditions
-----------------
Infection, Febrile Neutropenia, Acute Leukemia, Stem Cell Transplantation

Intervention / Treatment
-----------------
* Diagnostic Test: iDTECT Blood


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
-----------------
Minimum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Intervention/Treatment |
| --- |
|Diagnostic Test: iDTECT Blood|Next generation sequencing-based shot-gun metagenomic test for the diagnosis of viral or bacterial infections using blood samples|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of detection of clinically relevant bacterial or viral pathogen (CRBV) by iDTECT™ Blood as compared to conventional microbiological methods at inclusion | Sensitivity, specificity, negative predictive value, positive predictive value at inclusion | 7 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Antiobiotic use | Type of antibiotic, duration of antibiotic course | 9 months | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
metagenomic, infection, diagnosis