Back to resultsPharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients
Primary Purpose
Lung Transplant Infection, Fungal Infection
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
collection of blood samples for PK testing
Sponsored by
About this trial
This is an interventional diagnostic trial for Lung Transplant Infection focused on measuring posaconazole, PK blood sampling
Eligibility Criteria
Inclusion Criteria:
- 18 years of age and older receiving posaconazole post transplant as part of their care received a lung transplant
Exclusion Criteria:
- must meet inclusion criteria
Sites / Locations
- UPMC
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
'collection of blood samples for PK testing'
Arm Description
collection of PK samples around a dosing of Posaconazole
Outcomes
Primary Outcome Measures
measure the levels of posaconazole post dosing
pk samples will be obtained around dosing of medication and then analyzed for posaconazole levels
Secondary Outcome Measures
determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells
Full Information
NCT ID
NCT01419678
First Posted
August 12, 2011
Last Updated
December 5, 2014
Sponsor
University of Pittsburgh
Collaborators
Merck Sharp & Dohme LLC
1. Study Identification
Unique Protocol Identification Number
NCT01419678
Brief Title
Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients
Official Title
Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
December 2014
Overall Recruitment Status
Completed
Study Start Date
October 2011 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
December 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pittsburgh
Collaborators
Merck Sharp & Dohme LLC
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
This is a single center, observational study of posaconazole PK sampling in lung transplant recipients. The patients enrolled will have up to 6 (3ml) pk samples (a total of 18 ml) and one 10ml blood sample for a total collection of 28ml of blood obtained over the entire study. In addition, the investigators will collect medical record information and any excess BAL samples available during the study (tests done as part of the patient's clinical care and the samples would have been discarded once diagnosis was made).
Detailed Description
PK blood samples will be obtained around a clinical dosing of posaconazole
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lung Transplant Infection, Fungal Infection
Keywords
posaconazole, PK blood sampling
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
'collection of blood samples for PK testing'
Arm Type
Experimental
Arm Description
collection of PK samples around a dosing of Posaconazole
Intervention Type
Other
Intervention Name(s)
collection of blood samples for PK testing
Intervention Description
PK samples collected around dosing of posaconazole
Primary Outcome Measure Information:
Title
measure the levels of posaconazole post dosing
Description
pk samples will be obtained around dosing of medication and then analyzed for posaconazole levels
Time Frame
24 hours after dosing
Secondary Outcome Measure Information:
Title
determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells
Time Frame
1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
18 years of age and older receiving posaconazole post transplant as part of their care received a lung transplant
Exclusion Criteria:
must meet inclusion criteria
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ryan Shields, Pharm D
Organizational Affiliation
University of Pittsburgh
Official's Role
Principal Investigator
Facility Information:
Facility Name
UPMC
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients
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