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

NCT00177710 | Completed Phase 3

• 1 other identifier: IRB# 0408180
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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.

Conditions

Lung Transplantation; Fungal Infections

Outcome Measures

Primary Outcomes (1)

• To characterize the pharmacokinetic profile of liposomal amphotericin B achieved in the serum and epithelial lining fluid of the lung with four doses of liposomal amphotericin B administered via aerosolized nebulization in lung transplant recipients

Secondary Outcomes (1)

• 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.

Interventions

Amphotericin B DRUG

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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

Sponsors & Collaborators

• University of Pittsburgh: lead
• Astellas Pharma US, Inc.: collaborator

Study Sites (1)

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Mycoses

Interventions

Amphotericin B

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Intervention Hierarchy (Ancestors)

Macrolides; Polyketides; Lactones; Organic Chemicals

Study Officials

• Shahid Husain, MD

  University of Pittsburgh

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: September 13, 2005
• First Posted: September 15, 2005
• Study Start: January 1, 2006
• Study Completion: December 1, 2007
• Last Updated: December 17, 2008

Record last verified: 2008-12

Locations

US (1)