Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation
- Registration Number
- NCT04652050
- Lead Sponsor
- Hong Nguyen
- 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
Recruitment & Eligibility
- Status
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description lung transplants Tolsura Lung transplants on Tolsura for infection
- Primary Outcome Measures
Name Time Method 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 Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
UPMC
🇺🇸Pittsburgh, Pennsylvania, United States