Validation of an Index of Neutropenia (D-index) in Febrile Neutropenic Cancer Patients

• Status: Terminated
• Trial end date: 2013-12-01
• Target enrollment: 0
• Participant gender: All

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%).

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Universidade Federal do Rio de Janeiro
• Collaborator: Federal University of São Paulo
• Treatments: Antifungal Agents; Caspofungin; Clotrimazole; Miconazole

Criteria

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