Clinical trial · Interventional
Validation of an Index of Neutropenia (D-index) in Febrile Neutropenic Cancer Patients
Empirical Antifungal Treatment in Neutropenic Patients Stratified by Risk: Prospective Validation of an Algorithm Based on the D-index
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Low accrual
Summary
Brief summary (as posted)
The main objective of this study is to test prospectively the performance of an algorithm stratified by an index based on neutrophil counts in association with galactomannan assay and image tests to start an antifungal early therapy (empirical/preemptive) in neutropenic patients. Ths specific objectives are to determine the overall incidence of invasive fungal infections, use of antifungal agents, duration of hospitalization and mortality in this cohort, and to evaluate if this strategy is associated with a reduction in the expected use of antifungal agents if a classical empiric antifungal strategy was used, without an increase in the incidence of invasive fungal infections. This is a prospective, non randomized, non comparative study. Patients aged ≥ 18 years are eligible if they have acute leukemia, myelodysplasia or other baseline disease submitted to chemotherapy or to allogeneic stem cell transplantation with an expected duration of neutropenia (neutrophil count \<500cells/mm³) of at least 10 days. Exclusion criteria are patients with and a past history of or invasive mold infection and those who do not want to participate. The study has no comparator arm. However, the investigators intend to determine if the algorithm based on the D-index would result in a 50% reduction in the use of antifungal agents, if all patients with persistent fever and neutropenia received empiric antifungal therapy. Based on our database of \~2,000 episodes of febrile neutropenia, 36% of patients had persistent fever between days 4 and 7 of antibiotics and would receive empiric antifungal therapy. A total of 105 patients will be needed to demonstrate a 50% reduction in antifungal use if the investigators compared this cohort with a matched control historical cohort (alpha = 5%, beta = 20%).
Conditions
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Invasive Aspergillosis | — | UNRESOLVED | — |
| Invasive Fungal Infections | — | UNRESOLVED | — |
| Invasive Fusariosis | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| caspofungin as preemptive antifungal therapy | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- NO_INTERVENTION
- label
- preemptive
- description
- Patients with persistent fever and neutropenia despite appropriate antibacterial therapy
- interventionNames
- Drug: caspofungin as preemptive antifungal therapy
Primary outcomes (1)
- measure
- Incidence of suspected and documented mold infection, use of anti mold therapy, duration of hospitalization and death rate.
- timeFrame
- At the end of the episode of febrile neutropenia
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * age 18 years or more * acute myeloid leukemia or myelosysplasia undergoing induction remission or consolidation therapy * allogeneic stem cell transplant recipients Exclusion Criteria: * prior invasive mould infection
References
Publications (0)
Data not yet available