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

• Conditions: Invasive pulmonary aspergillosis in patients with acute myeloblastic or lymphoblastic leukaemia.; MedDRA version: 14.0Level: LLTClassification code 10022881Term: Invasive bronchopulmonary aspergillosisSystem Organ Class: 10021881 - Infections and infestations; Therapeutic area: Diseases [C] - Bacterial Infections and Mycoses [C01]

• Registration Number: EUCTR2011-000499-32-ES
• Lead Sponsor: FUNDACIÓ SANT JOAN DE DE

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2011-06-30
• Last Update Posted: 19 March 2012

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

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

Exclusion Criteria

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.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified