Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation

NCT ID: NCT04652050

Last Updated: 2023-04-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

WITHDRAWN

Study Classification

OBSERVATIONAL

Study Start Date

2020-12-01

Study Completion Date

2023-04-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Lung Transplant Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

lung transplants

Lung transplants on Tolsura for infection

Tolsura

Intervention Type DRUG

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.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Hong Nguyen

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Hong Nguyen

Professor

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Hong Nguyen, MD

Role: PRINCIPAL_INVESTIGATOR

UPMC and PITT

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

UPMC

Pittsburgh, Pennsylvania, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

STUDY20080119

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.