Open , multicenter, randomized trial comparing two therapeutic approaches for the treatment of invasive fungal infections in neutropenic onco-hematologic patients.Empiric vs. ``presumptive`` (preemptive) antifungal therapy. - EMPIRIC VS. ``PRESUMPTIVE`` ANTIFUNGAL TREATMENT.

Conditions: opportunistic fungal infections in neutropenic onco-hematologic patients
MedDRA version: 9.1Level: HLGTClassification code 10017528Term: Fungal infectious disorders

Registration Number: EUCTR2008-008382-35-IT

Lead Sponsor: Azienda Ospedaliera di Perugia

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria a)Sex: Male or female. b)Age: =/>18 years. c)Patients affected by acute leukemia (myeloid or lymphoid) or undergoing autologous HSCT. d)Hospitalization for standard chemotherapy or autologous stem-cell transplantation. e)Neutropenia : a neutrophil count of =/<500 cell/mm3 or a count of =/<1000 cell/mm3 that is expected to drop to <500 cell/mm3 and remain at this level for at least 10 days. f) Fever unresponsive to a previous adequate course of broad spectrum antibiotics (duration of therapy at least 96 hours): Fever: a single measurement of body temperature =/>38.3C or a temperature of =/>38.0C lasting =/>1 hour[7]. g) An initial WORK-UP (Time 0) (performed at least 96 hours before the randomization) including at least : 3 blood specimens,1 urine specimen and possibly 1 nasal swab,1 pharyngeal swab,1 rectal swab. h) Written informed consent to all study procedures must be obtained from all patients.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

Exclusion criteria a)History of one or more documented or suspected IFIs prior to the current febrile episode. b) Patients who have received allogeneic stem-cell transplantation. c) History of hypersensitivity to or intolerance of antifungal drug administered after randomization d) Concomitant treatment with other systemic antifungal drugs that can interfere with the evaluation of the study drugs. e) Patients whose mental condition renders them incapable of understanding the nature, purpose, and possible consequences of the study AND/OR of adhering to the present protocol AND/OR those displaying uncooperative attitudes or behavior with respect to the study. f) Patients with a life expectancy of less than 72 hours. g) Patients with any condition that, in the investigator`s judgment, could jeopardize the patient`s safety during his or her participation in the study OR prevent evaluation of the patient`s response to the study drug OR significantly reduce the likelihood that the patient will be able to complete treatment with the study drug assigned during the randomization process. h) Patients with altered liver function indicated by SGPT (ALAT), SGOT (ASAT), total bilirubin or alkaline phosphatase >5 times the upper limit of normal ranges. i) Patients with serum creatinine levels >1.5 x ULN (upper limit normal). l) Pregnancy (Women).