Ignite Creation Date:
2024-05-05 @ 11:54 AM
Last Modification Date:
2024-10-26 @ 9:16 AM
Study NCT ID:
NCT00177710
Status:
COMPLETED
Last Update Posted:
2008-12-17
First Post:
2005-09-13
Brief Title:
Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study
Sponsor:
University of Pittsburgh
Organization:
University of Pittsburgh
Study Overview
Official Title:
Pharmacokinetic Profile of Inhaled Liposomal Amphotericin B in Lung Transplant Recipients - Ambisome Study
Status:
COMPLETED
Status Verified Date:
2008-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 mgkgday of inhaled Ambisome for four days prior to the BAL bronchoalveolar lavage procedure The dosage of 1 mgkg was calculated by extrapolating the dosage of 16 mgkg 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 andor 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 ie 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
All four doses will be given in the presence of a physician andor 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 ie 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None