Validation of an Index of Neutropenia (D-index) in Febrile Neutropenic Cancer Patients
Status:
Terminated
Trial end date:
2013-12-01
Target enrollment:
Participant gender:
Summary
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%).