Lung Transplantation Clinical Trial
Official title:
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.
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.
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Allocation: Non-Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Prevention
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