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Inhalation of Liposomal Amphotericin B to Prevent Invasive Aspergillosis

NCT00263315 · Status: COMPLETED · Phase: PHASE2/PHASE3 · Type: INTERVENTIONAL · Enrollment: 320

Last updated 2006-08-18

No results posted yet for this study

Summary

A Phase II/III randomized double-blind study comparing the safety and the efficacy of a weekly administration of 25 mg nebulized AmBisome with nebulized placebo solution to prevent invasive pulmonary aspergillosis in neutropenic hemato-oncologic patients.

Conditions

  • Aspergillosis

Interventions

DRUG

nebulised liposomal amphotericin B

Sponsors & Collaborators

Principal Investigators

  • Bart JA Rijnders, MD, PhD · Erasmus Medical Center

  • Siem de Marie, MD, PhD · Erasmus Medical Center

  • Jan J Cornelissen, MD, PhD · Erasmus Medical Center

  • Lennert Slobbe, MD · Erasmus Medical Center

  • A Vulto, PhD · Erasmus Medical Center

  • M J Becker, PhD · Erasmus Medical Center

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31
Completion
2006-05-31

Countries

  • Netherlands

Study Locations

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Entities

Companies

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 NCT00263315 on ClinicalTrials.gov