Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation

Lung Transplant Infection Clinical Trial

— Tolsura  

Official title:

Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT04652050
• Other study ID #: STUDY20080119
• Status: Withdrawn
• Start date: December 1, 2020
• Est. completion date: April 1, 2023

Study information

• Verified date: April 2023
• Source: University of Pittsburgh
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial Summary

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

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 information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: April 1, 2023
• Est. primary completion date: April 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Lung Transplant Infection

Intervention

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.

Locations

Country	Name	City	State
United States	UPMC	Pittsburgh	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Hong Nguyen

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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