Clinical trial · Observational
New Diagnostics in Neutropenia
Performance of Emerging Microbiological Techniques for the Diagnosis of Severe Infections in Neutropenic Patients With Haematological Malignancies
- 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)
Mortality due to bloodstream infections in patients with neutropenia and haematological malignancies is high and optimal management is hampered by long turnaround times of conventional blood cultures. This is an observational study to assess the performance of T2 magnetic resonance, in diagnosing proven, probable and possible bloodstream infections as well as its theoretical impact on antimicrobial prescriptions in neutropenic patients with acute leukemia and bone marrow recipients.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Febrile Neutropenia | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| T2 magnetic resonance | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (1)
- measure
- Sensitivity and specificity of T2MR as compared to Blood Cultures for the diagnosis of proven, probable, and possible BSI as previously defined
- timeFrame
- 01/04/2022 - 31/03/2023
- description
- Sensitivity and specificity of T2 magnetic resonance will be calculated with 95% confidence intervals both for pathogen identification and resistance markers detection
Secondary outcomes (2)
- measure
- In patients with positive T2 results: Mean time to result of T2MR
- timeFrame
- 01/04/2022 - 31/03/2023
- description
- In patients with positive T2 results, the theoretical mean time to T2 results (if T2 assessment had been performed real time as part of the clinical laboratory workflow) will be assessed.
- measure
- In patients with positive T2 results: percentage of potential antimicrobial modifications according to T2 results
- timeFrame
- 01/04/2022 - 31/03/2023
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: Adult patients (\> 18 years old) affected by acute leukaemia and/or recipients of bone marrow transplantation for any disease indication (during the pre and post-transplant phase) who develop febrile neutropenia, where blood cultures (and possibly bronchoscopy) are ordered as per standard of care. Febrile neutropenia is defined as: * an ANC of \<500 cells/mm3 * a single temperature measurement of ≥38.0°C Exclusion Criteria: * Patients not able to provide informed consent * Death is deemed imminent
References
Publications (0)
Data not yet available