Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study
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.
|Study Design:||Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
|Official Title:||Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study|
- 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
- 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.
|Study Start Date:||January 2006|
|Study Completion Date:||December 2007|
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/kg for the surface area of the rat lung to the human lung surface area in a 60 kg individual.
All four doses will be given in the presence of a physician and/or study coordinator. The forty eight subjects will be randomized such that six subjects undergo the BAL at 1, 12, 24, 48, 72, 96, 120, and 168 hours after the last dose of inhaled Liposomal amphotericin B (AmBisome®).
A blood sample (5 ml) will be obtained prior to the fourth dose of study medication and on the day of bronchoscopy (pseudo steady state trough). Concentrations of amphotericin in the serum, and bronchoalveolar lavage will be measured at pre-specified intervals after administration of liposomal amphotericin B (AmBisome®) in lung transplant recipients undergoing routine bronchoscopy as mentioned earlier.
A 5 ml blood sample will be recovered at the time of bronchoscopy for the purpose of determination of serum amphotericin B concentration and for the determination of serum urea concentration.
The bronchoscopy and bronchoalveolar lavage of subjects is done as a part of routine transplant care. Subjects will be followed for the follow-up of results of bronchoscopy at the interval deemed necessary by their transplant pulmonologist. The samples (blood and bronchoalveolar samples) will be under the control of the principal investigator of this research project. To protect confidentiality, all personal identifiers (i.e., name, social security number, and birth date) will be removed (de-identified) and replaced with a specific code number. The information linking these code numbers to the corresponding subjects' identities will be kept in a separate, secure location (ID lab at 8th floor Scaife Hall). The investigators on this study will keep the samples indefinitely. Samples may be given to investigators outside of UPMC or may be utilized in future studies about infectious diseases. If the samples are given to investigators not associated with this study, the samples will be provided without any identifiers. No genetic testing will be done on the samples obtained.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00177710
|United States, Pennsylvania|
|University of Pittsburgh Medical Center|
|Pittsburgh, Pennsylvania, United States, 15213|
|Principal Investigator:||Shahid Husain, MD||University of Pittsburgh|