Nebulized Amphotericin B Lipid Complex in Invasive Pulmonary Aspergillosis in Paediatric Patients With Acute Leukaemia

• Status: Completed
• Trial end date: 2013-07-01
• Target enrollment: 0
• Participant gender: All

Summary

The trial evaluates the overall tolerability of the drug and the efficacy of aerosolised amphotericin B as a lipid complex (ABLC) for primary prophylaxis of invasive pulmonary aspergillosis (IPA) in pediatric patients with acute leukemia undergoing intensive chemotherapy.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Fundació Sant Joan de Déu
• Collaborator: Ministry of Health, Spain
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

1. Age: patients between 3 and 18 years.

2. Diagnosis of myeloblastic or lymphoblastic AL during intensive chemotherapy.

3. Informed consent of parents/guardians and/or assent of the patient has been obtained.

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.