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

NCT01615809 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2018-03-29

Study results available
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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.

Conditions

  • Invasive Pulmonary Aspergillosis
  • Lymphoblastic Leukaemia
  • Myeloblastic Leukaemia
  • Lymphoblastic Leukemia
  • Myeloblastic Leukemia

Interventions

DRUG

AMPHOTERICIN B

The study drug will be administered by inhalation, to hospitalised patients or outpatients in the day hospital.

Sponsors & Collaborators

  • Ministry of Health, Spain

    collaborator OTHER_GOV

  • Fundació Sant Joan de Déu

    lead OTHER

Principal Investigators

  • Jesus Estella, PhMD · Hospital Sant Joan de Deu

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
3 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2011-10-31
Primary Completion
2013-07-31
Completion
2013-07-31

Countries

  • Spain

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01615809 on ClinicalTrials.gov