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Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

NCT ID: NCT01419678

Last Updated: 2014-12-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-10-31

Study Completion Date

2014-12-31

Brief Summary

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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

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

Conditions

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Lung Transplant Infection Fungal Infection

Keywords

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posaconazole PK blood sampling

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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'collection of blood samples for PK testing'

collection of PK samples around a dosing of Posaconazole

Group Type EXPERIMENTAL

collection of blood samples for PK testing

Intervention Type OTHER

PK samples collected around dosing of posaconazole

Interventions

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collection of blood samples for PK testing

PK samples collected around dosing of posaconazole

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* 18 years of age and older receiving posaconazole post transplant as part of their care received a lung transplant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role collaborator

University of Pittsburgh

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Ryan Shields, Pharm D

Role: PRINCIPAL_INVESTIGATOR

University of Pittsburgh

Locations

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UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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PRO10110232

Identifier Type: -

Identifier Source: org_study_id