opportunistic fungal infections in neutropenic onco-hematologic patients MedDRA version: 9.1 Level: HLGT Classification code 10017528 Term: Fungal infectious disorders
Conditions
Interventions
Trade Name: ABELCET
Pharmaceutical Form: Solution for infusion
INN or Proposed INN: Amphotericin B
Concentration unit: mg/kg milligram(s)/kilogram
Concentration type: equal
Concentration number: 1-
T
Sponsors
Azienda Ospedaliera di Perugia
Eligibility
Sex/Gender
All
Inclusion criteria
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 =/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: 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).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To compare the empiric vs. the ``presumptive`` (pre-emptive) therapeutic approach in the treatment of Invasive Fungal Infections (IFI) in neutropenic patients affected by acute leukemia and/or undergoing autologous Haematopoietic Stem Cell Transplantation (HSCT). Primary Objectives: To compare efficacy, safety and costs of ``presumptive`` treatment with empirical antifungal therapy in persistently febrile neutropenic acute leukemia and autologous HSCT patients.;Secondary Objective: Secondary Objectives : To compare survival rates among patients treated with ``presumptive`` vs. empirical approach. To compare clinical outcomes of patients treated with ``presumptive`` vs. empirical approach. To evaluate the efficiency of a standardized WORK-UP in detecting Invasive Fungal Infections. To compare the use of other healthcare resources in patients treated with ``presumptive`` vs. empirical treatment. To compare the duration of hospitalization (from the onset of the suspected IFI) in patients treated with ``presumptive`` vs. empirical treatment.;Primary end point(s): The following efficacy parameters will be evaluated between the two treatment groups : Number of patients undergoing antifungal therapy; Number of documented IFI; Response to antifungal therapy; Costs | — |
Countries
Italy
Outcome results
None listed