E.1 Medical condition or disease under investigation |
E.1.1 | Medical condition(s) being investigated |
opportunistic fungal infections in neutropenic onco-hematologic patients |
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MedDRA Classification |
E.1.2 Medical condition or disease under investigation |
E.1.2 | Version | 9.1 |
E.1.2 | Level | HLGT |
E.1.2 | Classification code | 10017528 |
E.1.2 | Term | Fungal infectious disorders |
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E.1.3 | Condition being studied is a rare disease | No |
E.2 Objective of the trial |
E.2.1 | Main objective of the trial |
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. |
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E.2.2 | Secondary objectives of the trial |
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. |
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E.2.3 | Trial contains a sub-study | No |
E.3 | Principal 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. |
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E.4 | Principal 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). |
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E.5 End points |
E.5.1 | 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 |
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E.6 and E.7 Scope of the trial |
E.6 | Scope of the trial |
E.6.1 | Diagnosis | Yes |
E.6.2 | Prophylaxis | No |
E.6.3 | Therapy | Yes |
E.6.4 | Safety | No |
E.6.5 | Efficacy | Yes |
E.6.6 | Pharmacokinetic | No |
E.6.7 | Pharmacodynamic | No |
E.6.8 | Bioequivalence | No |
E.6.9 | Dose response | No |
E.6.10 | Pharmacogenetic | No |
E.6.11 | Pharmacogenomic | No |
E.6.12 | Pharmacoeconomic | Yes |
E.6.13 | Others | Yes |
E.6.13.1 | Other scope of the trial description |
Confronto tra differenti approcci terapeutici antifungini nel paziente neutropenico oncoematologico |
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E.7 | Trial type and phase |
E.7.1 | Human pharmacology (Phase I) | No |
E.7.1.1 | First administration to humans | No |
E.7.1.2 | Bioequivalence study | No |
E.7.1.3 | Other | No |
E.7.1.3.1 | Other trial type description | |
E.7.2 | Therapeutic exploratory (Phase II) | No |
E.7.3 | Therapeutic confirmatory (Phase III) | No |
E.7.4 | Therapeutic use (Phase IV) | Yes |
E.8 Design of the trial |
E.8.1 | Controlled | Yes |
E.8.1.1 | Randomised | Yes |
E.8.1.2 | Open | Yes |
E.8.1.3 | Single blind | No |
E.8.1.4 | Double blind | No |
E.8.1.5 | Parallel group | Yes |
E.8.1.6 | Cross over | No |
E.8.1.7 | Other | No |
E.8.2 | Comparator of controlled trial |
E.8.2.1 | Other medicinal product(s) | No |
E.8.2.2 | Placebo | No |
E.8.2.3 | Other | Yes |
E.8.2.3.1 | Comparator description |
Approccio diagnostico terapaeutico |
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E.8.3 |
The trial involves single site in the Member State concerned
| No |
E.8.4 | The trial involves multiple sites in the Member State concerned | Yes |
E.8.4.1 | Number of sites anticipated in Member State concerned | 30 |
E.8.5 | The trial involves multiple Member States | No |
E.8.6 Trial involving sites outside the EEA |
E.8.6.1 | Trial being conducted both within and outside the EEA | No |
E.8.6.2 | Trial being conducted completely outside of the EEA | Information not present in EudraCT |
E.8.7 | Trial has a data monitoring committee | Yes |
E.8.8 |
Definition of the end of the trial and justification where it is not the last
visit of the last subject undergoing the trial
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E.8.9 Initial estimate of the duration of the trial |
E.8.9.1 | In the Member State concerned years | 3 |
E.8.9.1 | In the Member State concerned months | 0 |
E.8.9.1 | In the Member State concerned days | |
E.8.9.2 | In all countries concerned by the trial years | 3 |
E.8.9.2 | In all countries concerned by the trial months | 0 |