Status:
COMPLETED
Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study
Lead Sponsor:
University of Pittsburgh
Collaborating Sponsors:
Astellas Pharma US, Inc.
Conditions:
Lung Transplantation
Fungal Infections
Eligibility:
All Genders
18-65 years
Phase:
PHASE3
Brief Summary
The purpose of this study is to determine the steady state concentrations of inhaled liposomal amphotericin B (Ambisome®) in lung transplant recipients via aerosolized nebulization.
Detailed Description
Each subject will receive 1 mg/kg/day of inhaled Ambisome® for four days prior to the BAL (bronchoalveolar lavage) procedure. The dosage of 1 mg/kg was calculated by extrapolating the dosage of 1.6 mg...
Eligibility Criteria
Inclusion
- Male and female lung transplant recipients at University of Pittsburgh Medical Center ≥ 18 years of age will be eligible for the study.
- Single or double lung transplant recipients
- Willing to be available at the testing center for 4 consecutive days
- Able to comprehend and complete informed consent
Exclusion
- Pregnant women or women capable of bearing children, who will not perform a urine pregnancy test
- Nursing mothers
- Subjects with hypersensitivity to amphotericin deoxycholate or liposomal amphotericin
- Subjects with a past history of bronchospasm associated with aerosol drug use
- Subjects with active bacterial or viral infection as defined by the current use of non-prophylactic antibiotic anti-viral medications
- Subjects with a forced expiratory volume in 1 second (FEV1) \< 30% predicted or forced vital capacity (FVC) \< 30% will not receive study medication.
- Subjects requiring supplemental oxygen
- Receipt of inhalational or intravenous (IV) amphotericin B within last 30 days
- Subjects with known fungal infection as per Mycoses Study Group (MSG) criteria on therapy with antifungal drugs or diagnosed on the day of bronchoscopy
- Serum creatinine \> 1.9 mg/dl on the day of screening
- Liver enzymes ALT/AST/alkaline phosphatase greater than two times the normal limit
- Concurrent intravenous aminoglycoside use
- Subject with fever \> 38.2°C
- Subjects on mechanical ventilation
Key Trial Info
Start Date :
January 1 2006
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2007
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00177710
Start Date
January 1 2006
End Date
December 1 2007
Last Update
December 17 2008
Active Locations (1)
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1
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213