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

Overview

Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia

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

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: April 30, 2019

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.

Interventions

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

Clinical Trial Outcome Measures

Primary Measures

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

Secondary Measures

  • Antiobiotic use
    • Time Frame: 9 months
    • Type of antibiotic, duration of antibiotic course

Participating in This Clinical Trial

Inclusion Criteria

1. Age > 5 years and weight > 16 Kg 2. 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 3. 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 4. Febrile episode (oral temperature > 38.3°C once, or 2 measures > 38.0°C taken 2h apart). Exclusion Criteria:

1. Known HIV infection or AIDS diagnosis 2. Already microbiologically confirmed infection 3. Patient status preventing the study test to be performed 4. Patient with an obvious infectious disease diagnosis requiring minimal additional microbiological documentation or confirmation

Gender Eligibility: All

Minimum Age: 5 Years

Maximum Age: N/A

Are Healthy Volunteers Accepted: No

Investigator Details

  • Lead Sponsor
    • Pathoquest
  • Provider of Information About this Clinical Study
    • Sponsor
  • Overall Contact(s)
    • Dangles, +33687137695, christine.dangles@pathoquest.com

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