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OpenTrials
Completed

NCT Number: NCT01419678

Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

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).

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Key information

Conditions

Lung Transplant Infection Bacterial Infections and Mycoses Fungal Infection Infections Mycoses

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

UPMC

Pittsburgh, Pennsylvania, 15213, United States

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

collection of blood samples for PK testing

Other

PK samples collected around dosing of posaconazole

Primary outcomes

  1. 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 outcomes

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

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University of Pittsburgh

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Aug 18, 2011
Registry last updated
Dec 8, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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