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Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01419678
First Posted: August 18, 2011
Last Update Posted: December 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
University of Pittsburgh
  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 Fungal Infection Other: collection of blood samples for PK testing

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

Resource links provided by NLM:


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 ]
    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 ]

Enrollment: 20
Study Start Date: October 2011
Study Completion Date: December 2014
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

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01419678


Locations
United States, Pennsylvania
UPMC
Pittsburgh, Pennsylvania, United States, 15213
Sponsors and Collaborators
University of Pittsburgh
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Ryan Shields, Pharm D University of Pittsburgh
  More Information

Responsible Party: University of Pittsburgh
ClinicalTrials.gov Identifier: NCT01419678     History of Changes
Other Study ID Numbers: PRO10110232
First Submitted: August 12, 2011
First Posted: August 18, 2011
Last Update Posted: December 8, 2014
Last Verified: December 2014

Keywords provided by University of Pittsburgh:
posaconazole
PK blood sampling

Additional relevant MeSH terms:
Infection
Communicable Diseases
Mycoses
Posaconazole
Antifungal Agents
Anti-Infective Agents
Trypanocidal Agents
Antiprotozoal Agents
Antiparasitic Agents
14-alpha Demethylase Inhibitors
Cytochrome P-450 Enzyme Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Steroid Synthesis Inhibitors
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs