Lung Transplant InfectionTolsuraNCT04652050

Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation

An observational study of Lung Transplant Infection, run by Hong Nguyen at 1 site in United States.

Withdrawn

Withdrawn. The study stopped before anyone enrolled.

Trial summary

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

Who is it for?: Ages 18 years and older
Conditions the study is for: Lung Transplant Infection
What is being tested?: Tolsura
How many people: 0 participants
Where: 1 siteUnited States
Study dates: 1 Dec 2020to 1 Apr 2023
How long will I take part?: 6 Months
Phase: Observational
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Study population: lung transplants on Tolsura that meet entry criteria

Who may be able to join

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.

Who cannot join

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

Show all 9Show fewer

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

Trial locations and contacts

1 site in 1 country.

United States1 site

UPMC
Pittsburgh, Pennsylvania, 15213

Other trials in United States

About this study

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

Read the 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

Conditions: Lung Transplant Infection
Being tested: Tolsura
Keywords: lung transplant

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

TolsuraDrug
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.

Study groups in NCT04652050
Study group	Role	What they receive
lung transplants		Lung transplants on Tolsura for infection Receives: Drug: Tolsura

What is being measured

The primary outcome is the main question the study is designed to answer.

PK Sampling-measure amount of drug in system
blood samples around a dosing of Tolsura to determine maximum plasma concentration
Measured: one day PK sampling

Secondary outcomes (1)

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
Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Dec 20201 Apr 2023

First posted3 Dec 2020
Study start1 Dec 2020
Primary completion1 Apr 2023
Study completion1 Apr 2023

Why it stopped: Patients are not interested to participate

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Lung Transplant InfectionStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Observational
Observational model: Cohort
Time perspective: Prospective
Enrolment: 0 participants (actual)
Target duration: 6 Months

IDs, dates and publications

ClinicalTrials.gov ID: NCT04652050
Sponsor's protocol ID: STUDY20080119
Acronym: Tolsura
Status last verified: Apr 2023
First submitted: 23 Nov 2020
Last updated: 24 Apr 2023
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Undecided: 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

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

Active, not recruitingPhase 3
RSV Vaccine in Transplant Recipients
Vaccine Response Impaired, Respiratory Syncytial Virus Infections
Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
RecruitingPhase 2
High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)
Immunization; Infection|Transplantation Infection|Influenza, Influenza
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome

All Lung Transplant Infection trials

Study at a glance

From the registry record, last updated by the sponsor on 24 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Evaluation of Tolsura When Used as Prophylaxis After Lung Transplantation
ClinicalTrials.gov ID: NCT04652050
Acronym / sponsor ID: Tolsura / STUDY20080119
Conditions: Lung Transplant Infection
Keywords: lung transplant
Study type: Observational
Recruitment status: WithdrawnReason stopped: Patients are not interested to participate
Enrolment: 0 participants (actual)
Lead sponsor: Hong NguyenUniversity, hospital or other
Study start: 1 Dec 2020 (actual)
Primary completion: 1 Apr 2023 (actual)
Study completion: 1 Apr 2023 (actual)
First posted: 3 Dec 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Observational model: Cohort
Time perspective: Prospective
Target follow-up: 6 Months
Number of arms: 1

Arm	Type	Receives
lung transplants	–	Drug: TolsuraLung transplants on Tolsura for infection

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult
Study population: lung transplants on Tolsura that meet entry criteria

Key inclusion criteria (4 listed)

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.

Key exclusion criteria (9 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
TolsuraPatients 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.	Drug	lung transplants

Primary outcome

PK Sampling-measure amount of drug in system
Time frame: one day PK sampling
blood samples around a dosing of Tolsura to determine maximum plasma concentration

1 secondary outcome

rates of infection post treatment with Tolsura
Time frame: 6 months

Results and safety

The study was withdrawn before enrolling participants, so there are no results.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2023.
Individual participant dataSharing planned: Undecided. 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

Related trials for Lung Transplant Infection

Active, not recruitingPhase 3
RSV Vaccine in Transplant Recipients
Vaccine Response Impaired, Respiratory Syncytial Virus Infections
Not yet recruitingPhase 1/2
A Study of Sequential Therapy With AHB-137 Injection Followed by TVAX-008 Injection in Participants Living With Chronic Hepatitis B (CHB)
Chronic Hepatitis B
RecruitingPhase 2
COVID-19 Booster and IIV Schedule in Immunocompromised Hosts
COVID 19, Influenza
RecruitingPhase 2
High vs. Standard Dose Influenza Vaccines in Lung Transplant (Repeater)
Immunization; Infection|Transplantation Infection|Influenza, Influenza
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Hong Nguyen, MD principal investigator

UPMC and PITT

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

An observational study of Lung Transplant Infection, run by Hong Nguyen at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: withdrawn, as of the sponsor's last update on 24 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was withdrawn before enrolling participants, so there are no results.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

PK Sampling-measure amount of drug in system (time frame: one day PK sampling). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04652050.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2023.