Evaluation of Tolsura When Used as Prophylaxis After Lung... | NCT04652050

Studies
Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation

NCT04652050

Sponsor

Hong Nguyen

Status

Withdrawn

Last Update Posted

Apr 24, 2023Actual

Enrollment

0Actual

Phase

Not provided

Conditions

Lung Transplant Infection

Interventions

Tolsura

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Apr 2023

Overall Recruitment Status or Expanded Access Status

Withdrawn

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Patients are not interested to participate

Expanded Access Info

Start Date

Dec 1, 2020Actual

Primary Completion Date

Apr 1, 2023Actual

Completion Date

Apr 1, 2023Actual

First Submitted Date

Nov 23, 2020

First Submission Date that Met QC Criteria

Dec 2, 2020

First Posted Date

Dec 3, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Apr 20, 2023

Last Update Posted Date

Apr 24, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Yes

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

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

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

6 Months

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

0Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
lung transplants		Lung transplants on Tolsura for infection	Drug: Tolsura

Interventions

Name	Type	Description	Arm Group Labels	Other Names
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.

Outcomes Module

Primary Outcomes

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 Outcomes

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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

lung transplants on Tolsura that meet entry criteria

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Hong Nguyen, MD	UPMC and PITT	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
UPMC		Pittsburgh	Pennsylvania	15213	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

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

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D017964	Itraconazole

Ancestor Terms

ID	Term
D014230	Triazoles
D001393	Azoles
D006573	Heterocyclic Compounds, 1-Ring
D006571	Heterocyclic Compounds

Browse Leaves

Not provided

Browse Branches

Not provided