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

• Conditions: Febrile Neutropenia; Stem Cell Transplantation; Infection; Acute Leukemia

• Registration Number: NCT03364257
• Lead Sponsor: Pathoquest

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.

Study Timeline

• Study First Submitted: 2017-11-28
• Study First Submitted QC: 2017-12-05
• Study First Posted: 2017-12-06
• Study Start: 2018-05-18
• Status Verified: 2018-12
• Last Update Submitted: 2019-03-19
• Last Update Posted: 2019-03-21
• Primary Completion: 2019-04-30
• Study Completion: 2019-05-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 97

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Antiobiotic use	9 months	Type of antibiotic, duration of antibiotic course

Trial Locations

Locations (5)

Hospital Robert Debré; 🇫🇷 Paris, France

Hosptial Saint Louis; 🇫🇷 Paris, France

Hospital Necker; 🇫🇷 Paris, France

Hospital Trousseau; 🇫🇷 Paris, France

Hospital Salpétrière; 🇫🇷 Paris, France