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.
| Condition | Intervention | Phase |
|---|---|---|
| Invasive Pulmonary Aspergillosis Lymphoblastic Leukaemia Myeloblastic Leukaemia Lymphoblastic Leukemia Myeloblastic Leukemia |
Drug: AMPHOTERICIN B | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | A Phase II Trial to Evaluate the Safety and Tolerability of Nebulised Amphotericin B Lipid Complex (ABELCET®) in the Prophylaxis of Invasive Pulmonary Aspergillosis During Prolonged Neutropenia in Paediatric Patients With Acute Leukaemia |
Date of article/Start date of trial: 4 June 2012
Trial Phase: Phase 2
clinical Trials Gov ID: NCT01615809
Trial status: Completed