Fungal Infection, Lung Transplant Infection
Conditions
Keywords
posaconazole, PK blood sampling
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).
Detailed description
PK blood samples will be obtained around a clinical dosing of posaconazole
Interventions
OTHERcollection of blood samples for PK testing
PK samples collected around dosing of posaconazole
Sponsors
Merck Sharp & Dohme LLC
University of Pittsburgh
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| measure the levels of posaconazole post dosing | 24 hours after dosing | pk samples will be obtained around dosing of medication and then analyzed for posaconazole levels |
Secondary
| Measure | Time frame |
|---|---|
| determine the posaconazole concentration within the pulmonary epithelial lining fluid (ELF) and alveolar cells | 1 year |
Countries
United States
Outcome results
None listed