Clinical trial · Observational
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
NCT03364257CI-TRIAL-00037723IDENTIFYunknownClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Prospective, multicentre French observational study assessing the performance and medico-economic utility of iDTECT Blood versus conventional microbiologic diagnosis in patients with febrile neutropenia
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Acute Leukemia | Acute Leukemia | ONTOLOGY_EXACT | 0.90 |
| Febrile Neutropenia | — | UNRESOLVED | — |
| Infection | — | UNRESOLVED | — |
| Stem Cell Transplantation | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| iDTECT Blood | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Rate of detection of clinically relevant bacterial or viral pathogen (CRBV) by iDTECT™ Blood as compared to conventional microbiological methods at inclusion
- timeFrame
- 7 months
- description
- Sensitivity, specificity, negative predictive value, positive predictive value at inclusion
Secondary outcomes (1)
- measure
- Antiobiotic use
- timeFrame
- 9 months
- description
- Type of antibiotic, duration of antibiotic course
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 5 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.