NCT01419678

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).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2011

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 12, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 18, 2011

Completed
1 month until next milestone

Study Start

First participant enrolled

October 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2014

Completed
Last Updated

December 8, 2014

Status Verified

December 1, 2014

Enrollment Period

3.2 years

First QC Date

August 12, 2011

Last Update Submit

December 5, 2014

Conditions

Lung Transplant InfectionFungal Infection

Keywords

posaconazolePK blood sampling

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (1)

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

    1 year

Study Arms (1)

'collection of blood samples for PK testing'

EXPERIMENTAL

collection of PK samples around a dosing of Posaconazole

Other: collection of blood samples for PK testing

Interventions

collection of blood samples for PK testingOTHER

PK samples collected around dosing of posaconazole

'collection of blood samples for PK testing'

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • years of age and older receiving posaconazole post transplant as part of their care received a lung transplant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

MeSH Terms

Conditions

Mycoses

Condition Hierarchy (Ancestors)

Bacterial Infections and MycosesInfections

Study Officials

  • Ryan Shields, Pharm D

    University of Pittsburgh

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 12, 2011

First Posted

August 18, 2011

Study Start

October 1, 2011

Primary Completion

December 1, 2014

Study Completion

December 1, 2014

Last Updated

December 8, 2014

Record last verified: 2014-12

Locations

US(1)