Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)

• Status: Completed
• Trial end date: 2005-09-01
• Target enrollment: 0
• Participant gender: All

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 aspergillosis (IA) in their lungs. Additionally, the investigators hope to determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pittsburgh
• Collaborator: Enzon Pharmaceuticals, Inc.
• Treatments: Amphotericin B; Liposomal amphotericin B

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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