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Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

This study is currently recruiting participants.
Verified January 2013 by University of Pittsburgh
Sponsor:
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
History of Changes
  Purpose

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).


Condition Intervention
Lung Transplant Infection
 Other: collection of blood samples for PK testing

Study Type: Interventional
Study Design: Endpoint Classification: Pharmacokinetics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Pittsburgh:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Estimated Enrollment: 20
Study Start Date: October 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 'collection of blood samples for PK testing'
collection of PK samples around a dosing of Posaconazole
 Other: collection of blood samples for PK testing
PK samples collected around dosing of posaconazole

Detailed Description:

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

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01419678

Contacts
Contact: Ryan Shields, Pharm D 412-864-3745 shieldsrk@upmc.edu
Contact: Diana Pakstis, RN, BSN 412-648-6553 dlp5@pitt.edu

Locations
United States, Pennsylvania
UPMC Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Ryan Shields, Pharm D     412-864-3745     shieldsrk@upmc.edu    
Contact: Diana Pakstis, RN, BSN     412-648-6553     dlp5@pitt.edu    
Principal Investigator: Ryan Shields, Pharm D            
Sponsors and Collaborators
University of Pittsburgh
Merck
Investigators
Principal Investigator: Ryan Shields, Pharm D University of Pittsburgh
  More Information

No publications provided

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01419678     History of Changes
Other Study ID Numbers: PRO10110232
Study First Received: August 12, 2011
Last Updated: January 15, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by University of Pittsburgh:
posaconazole
PK blood sampling

Additional relevant MeSH terms:
Posaconazole
Antifungal Agents
Anti-Infective Agents
Therapeutic Uses
 Pharmacologic Actions
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents

ClinicalTrials.gov processed this record on May 21, 2013