Status:
COMPLETED
Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Enzon Pharmaceuticals, Inc.
Conditions:
Lung Transplantation
Fungal Infections
Eligibility:
All Genders
18-70 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®) in lung transplant recipients who are positive for invasive a...
Detailed Description
Subject's visit for teaching and administration of the first dose of aerosolized liposomal Amphotericin will be performed at the specified intervals before the scheduled bronchoscopy. Subject will re...
Eligibility Criteria
Inclusion
- Male and female lung transplant recipients at University of Pittsburgh Medical Center ≥ 18yrs of age will be eligible for the study. Subjects HIV status will not determine the exclusion from study.
Exclusion
- Pregnant women or women who are currently breast-feeding an infant
- Hypersensitive to amphotericin deoxycholate or lipid complex amphotericin B (Abelcet ®)
- Have a documented fungal infection
- Receipt of inhalational or IV amphotericin B within last 30 days
- Have a Temp ≥ 38ºC
- Hypoxemic (pulse oximeter \< 92% at room air.)
- On mechanical ventilator
Key Trial Info
Start Date :
September 1 2004
Trial Type :
INTERVENTIONAL
End Date :
September 1 2005
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00177684
Start Date
September 1 2004
End Date
September 1 2005
Last Update
December 17 2008
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213