Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients
This study is currently recruiting participants.
Verified January 2013 by University of Pittsburgh
Sponsor:
University of Pittsburgh
Collaborator:
Merck
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01419678
First received: August 12, 2011
Last updated: January 15, 2013
Last verified: January 2013
| Tracking Information | |||||||||
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| First Received Date ICMJE | August 12, 2011 | ||||||||
| Last Updated Date | January 15, 2013 | ||||||||
| Start Date ICMJE | October 2011 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Current Primary Outcome Measures ICMJE |
measure the levels of posaconazole post dosing [ Time Frame: 24 hours after dosing ] [ Designated as safety issue: No ] pk samples will be obtained around dosing of medication and then analyzed for posaconazole levels |
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| Original Primary Outcome Measures ICMJE |
determine the intracellular concentrations of posaconazole within patients' peripheral blood monocytes (PBM), polymorphonuclear neutrophils (PMN), and red blood cells (RBC) [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Change History | Complete list of historical versions of study NCT01419678 on ClinicalTrials.gov Archive Site | ||||||||
| Current Secondary Outcome Measures ICMJE |
determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells [ Time Frame: 1 year ] [ Designated as safety issue: No ] | ||||||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||||||
| Descriptive Information | |||||||||
| Brief Title ICMJE | Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients | ||||||||
| Official Title ICMJE | Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients | ||||||||
| 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). |
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| Detailed Description | PK blood samples will be obtained around a clinical dosing of posaconazole |
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| Study Type ICMJE | Interventional | ||||||||
| Study Phase | Not Provided | ||||||||
| Study Design ICMJE | Endpoint Classification: Pharmacokinetics Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
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| Condition ICMJE | Lung Transplant Infection | ||||||||
| Intervention ICMJE | Other: collection of blood samples for PK testing
PK samples collected around dosing of posaconazole |
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| Study Arm (s) | Experimental: 'collection of blood samples for PK testing'
collection of PK samples around a dosing of Posaconazole
Intervention: Other: collection of blood samples for PK testing |
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| Publications * | Not Provided | ||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||
| Recruitment Status ICMJE | Recruiting | ||||||||
| Estimated Enrollment ICMJE | 20 | ||||||||
| Estimated Completion Date | December 2015 | ||||||||
| Estimated Primary Completion Date | December 2014 (final data collection date for primary outcome measure) | ||||||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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| Gender | Both | ||||||||
| Ages | 18 Years and older | ||||||||
| Accepts Healthy Volunteers | No | ||||||||
| Contacts ICMJE |
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| Location Countries ICMJE | United States | ||||||||
| Administrative Information | |||||||||
| NCT Number ICMJE | NCT01419678 | ||||||||
| Other Study ID Numbers ICMJE | PRO10110232 | ||||||||
| Has Data Monitoring Committee | Yes | ||||||||
| Responsible Party | University of Pittsburgh | ||||||||
| Study Sponsor ICMJE | University of Pittsburgh | ||||||||
| Collaborators ICMJE | Merck | ||||||||
| Investigators ICMJE |
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| Information Provided By | University of Pittsburgh | ||||||||
| Verification Date | January 2013 | ||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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