Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation

NCT04652050 | Withdrawn DMC FDA Drug

• 1 other identifier: STUDY20080119
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Lung Transplant Infection

Keywords

lung transplant

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• rates of infection post treatment with Tolsura

  6 months

Study Arms (1)

lung transplants

Lung transplants on Tolsura for infection

Drug: Tolsura

Interventions

Tolsura 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.

lung transplants

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

lung transplants on Tolsura that meet entry criteria

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Hong Nguyen: lead

Study Sites (1)

UPMC

Pittsburgh, Pennsylvania, 15213, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

excess biological samples collected as part of the patient's clinical care will be obtained if available for further testing/analysis for amounts of Tolsura

MeSH Terms

Interventions

Itraconazole

Intervention Hierarchy (Ancestors)

Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Piperazines

Study Officials

• Hong Nguyen, MD

  UPMC and PITT

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 6 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 3, 2020
• Study Start: December 1, 2020
• Primary Completion: April 1, 2023
• Study Completion: April 1, 2023
• Last Updated: April 24, 2023

Record last verified: 2023-04

Locations

US (1)