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

Completed · Phase 3

Conditions studied: Lung Transplantation, Fungal Infections

In brief

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

Key facts

Study ID

NCT00177684

Run by

University of Pittsburgh

People needed

48

Starts

2004-09-01

Expected to finish

2005-09-01

Last updated by the study team

2008-12-17

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States

Full record on ClinicalTrials.gov

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