Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

N/ACompletedNCT01419678

University of Pittsburgh20 enrolled

Overview

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

Study Type

INTERVENTIONAL

Allocation

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

Conditions

Lung Transplant Infection Fungal Infection

Interventions

collection of blood samples for PK testingOTHER

PK samples collected around dosing of posaconazole

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

UPMC

Pittsburgh, Pennsylvania, United States

Outcomes

Primary Outcomes

measure the levels of posaconazole post dosing

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

Time frame: 24 hours after dosing

Secondary Outcomes

determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells

Time frame: 1 year

Data from ClinicalTrials.gov

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