The use and efficacy of empirical versus pre-emptive therapy in the management of fungal infections: the HEMA e-Chart Project.

Abstract

BACKGROUND:

Neutropenic patients with persistent fever despite antibiotic therapy are managed with empirical or pre-emptive antifungal therapy. The aim of the present study was to evaluate the current clinical use and efficacy of these two approaches in patients with high risk hematologic conditions.

DESIGN AND METHODS:

An electronic medical record system, the "Hema e-Chart", was designed and implemented to collect information prospectively on infectious complications, particularly on invasive fungal diseases, in patients with hematologic malignancies treated with chemotherapy and/or autologous or allogenic hemopoietic stem cell transplantation. The patients were enrolled from Hematology units distributed widely across Italy.

RESULTS:

Three hundred and ninety-seven adults with hematologic malignancies treated with chemotherapy with persistent fever and suspected invasive fungal disease were evaluable for the study (190 treated had been treated with empirical antifungal therapy and 207 with preemptive antifungal therapy). There was a significantly lower incidence of proven/probable invasive fungal diseases in patients treated with empirical antifungal therapy (n=14, 7.4%) than in patients treated with pre-emptive therapy (n=49, 23.7%) (P<0.001). The rate of deaths attributable to invasive fungal diseases was significantly lower in subjects treated with empirical antifungal therapy (1 case; 7.1%) than in subjects treated with pre-emptive therapy (11 cases; 22.5%) (P=0.002).

CONCLUSIONS:

These data indicate that empirical antifungal treatment decreased the incidence of invasive fungal disease and of attributable mortality with respect to a pre-emptive antifungal approach in neutropenic febrile patients with hematologic malignancies. (ClinicalTrials.gov Identifier: NCT01069887).

• Authors: Livio Pagano, Morena Caira, Annamaria Nosari, Chiara Cattaneo, Rosa Fanci, Alessandro Bonini, Nicola Vianelli, Maria Grazia Garzia, Mario Mancinelli, Maria Elena Tosti, Mario Tumbarello, Pierluigi Viale, Franco Aversa, Giuseppe Rossi, HEMA e-Chart Group
• Journal: Haematologica (Haematologica) Vol. 96 Issue 9 Pg. 1366-70 (Sep 2011) ISSN: 1592-8721 [Electronic] Italy
• PMID: 21565903 (Publication Type: Clinical Trial, Journal Article, Research Support, Non-U.S. Gov't)

Chemical References

• Antifungal Agents
• Antineoplastic Agents

Topics

• Adolescent
• Adult
• Aged
• Aged, 80 and over
• Antibiotic Prophylaxis
• Antifungal Agents (therapeutic use)
• Antineoplastic Agents (therapeutic use)
• Female
• Hematologic Neoplasms (complications, therapy)
• Hematopoietic Stem Cell Transplantation (adverse effects)
• Humans
• Kaplan-Meier Estimate
• Male
• Middle Aged
• Mycoses (drug therapy, etiology, prevention & control)
• Neutropenia (etiology)
• Young Adult