Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation

• Sponsor: Hong Nguyen (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04652050
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Anticipated Duration (Months): 41
• Patients Per Site Per Month: 1.2

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Lung Transplant Infection	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 Design

• Study Type: Observational [Patient Registry]
• Anticipated Enrollment: 50 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation
• Anticipated Study Start Date: Aug 1, 2022
• Anticipated Primary Completion Date: Dec 31, 2025
• Anticipated Study Completion Date: Dec 31, 2025

Arms and Interventions

Arm	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.

Outcome Measures

Primary Outcome Measures

1. 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

1. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	UPMC	Pittsburgh	Pennsylvania	United States	15213

Sponsors and Collaborators

• Hong Nguyen

Investigators

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Hong Nguyen, Professor, University of Pittsburgh
• ClinicalTrials.gov Identifier: NCT04652050
• Other Study ID Numbers: STUDY20080119
• First Posted: Dec 3, 2020
• Last Update Posted: Jun 14, 2022
• Last Verified: Jun 1, 2022

• Individual Participant Data (IPD) Sharing Statement: Undecided
• Plan to Share IPD: Undecided
• 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
• Keywords provided by Hong Nguyen, Professor, University of Pittsburgh: lung transplant

Study Results

No Results Posted as of Jun 14, 2022