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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
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.
Details
| Lead sponsor | Fundació Sant Joan de Déu |
|---|---|
| Phase | Phase 2 |
| Status | COMPLETED |
| Enrolment | 32 |
| Start date | 2011-10 |
| Completion | 2013-07 |
Conditions
- Invasive Pulmonary Aspergillosis
- Lymphoblastic Leukaemia
- Myeloblastic Leukaemia
- Lymphoblastic Leukemia
- Myeloblastic Leukemia
Interventions
- AMPHOTERICIN B
Primary outcomes
- Number of Participants With Adverse Events That Results in the Interruption of Treatment, as a Measure of Safety and Tolerability — at the Baseline visit (week 1) and during the Last week of treatment, up to 6 weeks
is assessed by the proportion of patients who discontinue prophylactic treatment with Abelcet® due to an adverse event that is related or not to the study drug or for intolerability to it. The last week of treatment will have a different calendar for each participant, depending on the number of cicles needed by each patient (it has been anticipated up to 5 cicles of 2-6 weeks each).
Countries
Spain