Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation (Tolsura)

This is a single-center, observational study of Tolsura PK sampling in lung transplant recipients

Study Overview

• Status: Withdrawn
• Conditions: Lung Transplant Infection
• Intervention / Treatment: Drug: Tolsura

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

• Study Type: Observational

Contacts and Locations

• Study Contact: Name: Hong Nguyen, MD; Phone Number: 412-383-5193; Email: mhn5@pitt.edu
• Study Contact Backup: Name: Kailey Hughes Kramer, MPH; Phone Number: 412-648-6453; Email: hugheskl4@upmc.edu

Study Locations

• United States
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • UPMC

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

lung transplants on Tolsura that meet entry criteria

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
lung transplants; Lung transplants on Tolsura for infection	Drug: Tolsura; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
PK Sampling-measure amount of drug in system	blood samples around a dosing of Tolsura to determine maximum plasma concentration	one day PK sampling

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
rates of infection post treatment with Tolsura	follow lung transplant recipients till end of Tolsura treatment and determine rates of infection for as well as type of infections	6 months

Collaborators and Investigators

• Sponsor: Hong Nguyen
• Investigators: Principal Investigator: Hong Nguyen, MD, UPMC and PITT

Study record dates

Study Major Dates

• Study Start (Actual): December 1, 2020
• Primary Completion (Actual): April 1, 2023
• Study Completion (Actual): April 1, 2023

Study Registration Dates

• First Submitted: November 23, 2020
• First Submitted That Met QC Criteria: December 2, 2020
• First Posted (Actual): December 3, 2020

Study Record Updates

• Last Update Posted (Actual): April 24, 2023
• Last Update Submitted That Met QC Criteria: April 20, 2023
• Last Verified: April 1, 2023

More Information

Terms related to this study

• Keywords: lung transplant
• Other Study ID Numbers: STUDY20080119

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: If data is shared all data provided de identified using alpha/numeric codes and MTA and/or DUA's will be in put in place prior to sharing

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No