Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

This study is currently recruiting participants. (see Contacts and Locations)
Verified July 2013 by University of Pittsburgh
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Pittsburgh
ClinicalTrials.gov Identifier:
NCT01419678
First received: August 12, 2011
Last updated: July 29, 2013
Last verified: July 2013

August 12, 2011
July 29, 2013
October 2011
December 2014   (final data collection date for primary outcome measure)
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
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 ]
Complete list of historical versions of study NCT01419678 on ClinicalTrials.gov Archive Site
determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients
Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

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).

PK blood samples will be obtained around a clinical dosing of posaconazole

Interventional
Not Provided
Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Lung Transplant Infection
Other: collection of blood samples for PK testing
PK samples collected around dosing of posaconazole
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
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
20
December 2015
December 2014   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact: Ryan Shields, Pharm D 412-864-3745 shieldsrk@upmc.edu
Contact: Diana Pakstis, RN, BSN 412-648-6553 dlp5@pitt.edu
United States
 
NCT01419678
PRO10110232
Yes
University of Pittsburgh
University of Pittsburgh
Merck Sharp & Dohme Corp.
Principal Investigator: Ryan Shields, Pharm D University of Pittsburgh
University of Pittsburgh
July 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP