Lung Transplantation Clinical Trial
Official title:
Pharmacokinetic Profiles of Inhaled Lipid Complex Amphotericin B (Abelcet ®)
Verified date | December 2008 |
Source | University of Pittsburgh |
Contact | n/a |
Is FDA regulated | No |
Health authority | United States: Institutional Review Board |
Study type | Interventional |
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
Status | Completed |
Enrollment | 48 |
Est. completion date | September 2005 |
Est. primary completion date | |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 70 Years |
Eligibility |
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 |
Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics/Dynamics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
United States | University of Pittsburgh Medical Center | Pittsburgh | Pennsylvania |
Lead Sponsor | Collaborator |
---|---|
University of Pittsburgh | Enzon Pharmaceuticals, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | To determine the optimal delivery system for the nebulization of the lipid complex amphotericin B (Abelcet ®). | |||
Secondary | To determine the concentrations of amphotericin B achieved in the epithelial lining fluid, and serum with the administration of a four days of lipid complex of amphotericin B (Abelcet ®) (QD) via aerosolized nebulization in lung transplant recipients. |
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