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Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

Not Applicable
Completed
Conditions
Lung Transplant Infection
Fungal Infection
Interventions
Other: collection of blood samples for PK testing
Registration Number
NCT01419678
Lead Sponsor
University of Pittsburgh
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

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
20
Inclusion Criteria
  • 18 years of age and older receiving posaconazole post transplant as part of their care received a lung transplant
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Exclusion Criteria
  • must meet inclusion criteria
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Study & Design

Study Type
INTERVENTIONAL
Study Design
SINGLE_GROUP
Arm && Interventions
GroupInterventionDescription
'collection of blood samples for PK testing'collection of blood samples for PK testingcollection of PK samples around a dosing of Posaconazole
Primary Outcome Measures
NameTimeMethod
measure the levels of posaconazole post dosing24 hours after dosing

pk samples will be obtained around dosing of medication and then analyzed for posaconazole levels

Secondary Outcome Measures
NameTimeMethod
determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells1 year

Trial Locations

Locations (1)

UPMC

🇺🇸

Pittsburgh, Pennsylvania, United States

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