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

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

Status

UNKNOWN

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03364257

Acronym

IDENTIFY

Enrollment

Registered

2017-12-06

Start date

2018-05-18

Completion date

2019-05-31

Last updated

2019-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Leukemia, Febrile Neutropenia, Infection, Stem Cell Transplantation

Keywords

metagenomic, infection, diagnosis

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.

Interventions

DIAGNOSTIC_TESTiDTECT Blood

Next generation sequencing-based shot-gun metagenomic test for the diagnosis of viral or bacterial infections using blood samples

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

5 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
Antiobiotic use	9 months	Type of antibiotic, duration of antibiotic course

Countries

France

Contacts

Primary ContactDangles

christine.dangles@pathoquest.com+33687137695

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026