Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients

NCT ID: NCT06494033

Last Updated: 2025-03-26

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

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Recruitment Status

RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-12-03

Study Completion Date

2026-06-30

Brief Summary

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The purpose of this study is to evaluate the clinical outcomes of Cytomegalovirus (CMV) virus in the participants' body. Therefore, the study team will follow the participants' immunological response based on the Cytomegalovirus (CMV) virus testing.

Detailed Description

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Conditions

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Lung Diseases

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prophylaxis guided by Cytomegalovirus-specific T cell Immunity

The immunological response of participants in this group will be followed for 1 year.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

1. Adult patients over 18 years of age
2. Lung transplant candidates with positive CMV IgG
3. Anticipated to receive a lung transplant (both double lung and single lung)

Exclusion Criteria

1. Negative CMV IgG prior transplant
2. Pregnant or breastfeeding women
3. HIV infected patients
4. Combined organ (e.g., lung-heart, lung-kidney) transplant candidates
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Eurofins Viracor, LLC

UNKNOWN

Sponsor Role collaborator

University of Miami

OTHER

Sponsor Role lead

Responsible Party

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Yoichiro Natori

Associate Professor of Clinical

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Yoichiro Natori, MD

Role: PRINCIPAL_INVESTIGATOR

University of Miami

Locations

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University of Miami

Miami, Florida, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Yoichiro Natori, MD

Role: CONTACT

3053556323

Lissett Moni

Role: CONTACT

3053555418

Facility Contacts

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Yoichiro Natori, MD

Role: primary

3053556323

Lissett Moni

Role: backup

3053555418

Other Identifiers

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20230432

Identifier Type: -

Identifier Source: org_study_id

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