At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 32 enrolled
Drug / intervention
AMPHOTERICIN Bdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
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
In Brief
A Phase 2 clinical trial evaluating AMPHOTERICIN B for Invasive Pulmonary Aspergillosis and 4 related conditions. Completed, enrolled 32 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsInvasive Pulmonary Aspergillosis, Lymphoblastic Leukaemia, Myeloblastic Leukaemia, Lymphoblastic Leukemia, Myeloblastic Leukemia
CountriesSpain
CollaboratorsMinistry of Health, Spain
Timeline
Phase 2CompletedFinished
201220132014201520162017201820192020202120222023202420252026
Enrollment StartOct 2011
First PostedJun 2012
Primary CompletionJul 2013
TodayJul 2026
First PostedJun 11, 2012
Enrollment StartOct 1, 2011
Primary CompletionJul 1, 2013
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 14.1 years ago
Interventions
AMPHOTERICIN Bdrug
The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.