Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

Fungal Infection Clinical Trial

Official title:

Pharmacokinetic Analysis of Posaconazole in Lung Transplant Recipients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01419678
• Other study ID #: PRO10110232
• Status: Completed
• Phase: N/A
• First received: August 12, 2011
• Last updated: December 5, 2014
• Start date: October 2011
• Est. completion date: December 2014

Study information

• Verified date: December 2014
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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).

Description:

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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

Study Design

Endpoint Classification: Pharmacokinetics Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Fungal Infection
• Infection
• Lung Transplant Infection
• Mycoses

Intervention

Other:
• collection of blood samples for PK testing
PK samples collected around dosing of posaconazole

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
University of Pittsburgh	Merck Sharp & Dohme Corp.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	measure the levels of posaconazole post dosing	pk samples will be obtained around dosing of medication and then analyzed for posaconazole levels	24 hours after dosing	No
Secondary	determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells		1 year	No