title: 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.
  
  
  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.affiliation: Istituto di Ematologia Università Cattolica del Sacro Cuore, Roma Italia. lpagano@rm.unicatt.it
authors.forename: Livio
authors.initials: L
authors.lastname: Pagano
authors.forename: Morena
authors.initials: M
authors.lastname: Caira
authors.forename: Annamaria
authors.initials: A
authors.lastname: Nosari
authors.forename: Chiara
authors.initials: C
authors.lastname: Cattaneo
authors.forename: Rosa
authors.initials: R
authors.lastname: Fanci
authors.forename: Alessandro
authors.initials: A
authors.lastname: Bonini
authors.forename: Nicola
authors.initials: N
authors.lastname: Vianelli
authors.forename: Maria Grazia
authors.initials: MG
authors.lastname: Garzia
authors.forename: Mario
authors.initials: M
authors.lastname: Mancinelli
authors.forename: Maria Elena
authors.initials: ME
authors.lastname: Tosti
authors.forename: Mario
authors.initials: M
authors.lastname: Tumbarello
authors.forename: Pierluigi
authors.initials: P
authors.lastname: Viale
authors.forename: Franco
authors.initials: F
authors.lastname: Aversa
authors.forename: Giuseppe
authors.initials: G
authors.lastname: Rossi
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D019072:Antibiotic Prophylaxis; D000935:Antifungal Agents / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use; D005260:Female; D019337:Hematologic Neoplasms / Q000150:complications / Q000628:therapy; D018380:Hematopoietic Stem Cell Transplantation / Q000009:adverse effects; D006801:Humans; D053208:Kaplan-Meier Estimate; D008297:Male; D008875:Middle Aged; D009181:Mycoses / Q000188:drug therapy* / Q000209:etiology / Q000517:prevention & control; D009503:Neutropenia / Q000209:etiology; D055815:Young Adult
chemical_list: D000935:Antifungal Agents; D000970:Antineoplastic Agents