Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study

Completed · Phase 3

Conditions studied: Lung Transplantation, Fungal Infections

In brief

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.

Key facts

Study ID

NCT00177710

Run by

University of Pittsburgh

People needed

48

Starts

2006-01-01

Expected to finish

2007-12-01

Last updated by the study team

2008-12-17

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

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

Full record on ClinicalTrials.gov

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