A PHASE II CLINICAL TRIAL TO EVALUATE THE SAFETY AND TOLERABILITY OF AMPHOTERICIN B LIPID COMPLEX (ABELCET®) FOR THE PROPHYLAXIS OF INVASIVE PULMONARY ASPERGILLOSIS DURING PROLONGED NEUTROPENIA IN PAEDIATRIC PATIENTS WITH ACUTE LEUKAEMIA

FUNDACIÓ SANT JOAN DE DE0 个研究点开始时间: 2011年6月30日最近更新: 2012年3月19日

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•1. Age: patients between 3 and 18 years.
•2. Diagnosis of myeloblastic or lymphoblstic AL during intensive chemotherapy.
•3. Informed consent of parents/guardians and/or assent of the patient has been obtained.
•Are the trial subjects under 18? yes
•Number of subjects for this age range: 30
•F.1.2 Adults (18-64 years) no
•F.1.2.1 Number of subjects for this age range
•F.1.3 Elderly (>=65 years) no
•F.1.3.1 Number of subjects for this age range

•1.Probable or proven invasive pulmonary fungal infection before entering the trial.
•2.Previous chronic renal impairment or baseline serum creatinine > 2.5 mg /dL
•3.Severe hepatic impairment.
•4.Moderate-severe asthma being treated pharmacologically.
•5.Antifungal treatment for filamentous fungi in the last 4 weeks.
•6.Participating or have participated in a clinical trial during the last 4 weeks.
•7.Mentally retarded
•8.Known allergy or hypersensitivity to the active ingredient of the study drug or to any of its excipients.
•9.Any serious concomitant disease that in the investigator?s opinion could compromise the completion of the trial or affect the patient?s tolerability to this treatment.
•10.Pregnancy (in women of fertile age).
•11.Breast-feeding.
•Patients are defined as having probable IFI when their radiological image is suggestive of fungal infection and they have positive antigenemia for Aspergillus. IFI would be proven when the presence of Aspergillus is confirmed in aspirate culture or by lung biopsy.

发起方

FUNDACIÓ SANT JOAN DE DE