Lung Transplant Infection
Conditions
Keywords
lung transplant
Brief summary
This is a single-center, observational study of Tolsura PK sampling in lung transplant recipients
Detailed description
Patients who are receiving Tolsura as part of their clinical care will be asked to enroll and EMR data and excess biological samples will be collected
Interventions
DRUGTolsura
Patients fulfilling the inclusion criteria (see above) and placed on Tolsura for prophylaxis, and signed informed consent to participate in this study will be part of the study.
Sponsors
Hong Nguyen
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 18 years of age and older * hospitalized at UPMC * placed on Tolsura prophylactically by clinical team * patients who have had or will have a lung transplant.
Exclusion criteria
* redo lung transplant * recipient with dual liver-lung transplant * patients with previous history of SOT * including other organ transplantation * patients with known pre-transplant colonization with moulds resistant to azoles * patients with intra-transplant positive cultures for moulds in either transplant recipient or his/her donor * patients with a history of hypersensitivity reaction to an azole agent * patients who are kept NPO (nothing by mouth, including meds) * recipients or donor with HepC PCR positive
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| PK Sampling-measure amount of drug in system | one day PK sampling | blood samples around a dosing of Tolsura to determine maximum plasma concentration |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| rates of infection post treatment with Tolsura | 6 months | follow lung transplant recipients till end of Tolsura treatment and determine rates of infection for as well as type of infections |
Countries
United States
Outcome results
None listed