NCT06494033

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
100

participants targeted

Target at P50-P75 for all trials

Timeline
5mo left

Started Jul 2024

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress84%
Jul 2024Dec 2026

First Submitted

Initial submission to the registry

July 2, 2024

Completed
1 day until next milestone

Study Start

First participant enrolled

July 3, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

July 10, 2024

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 30, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 30, 2026

Last Updated

March 23, 2026

Status Verified

March 1, 2026

Enrollment Period

2.5 years

First QC Date

July 2, 2024

Last Update Submit

March 18, 2026

Conditions

Lung Diseases

Outcome Measures

Primary Outcomes (1)

  • Positive CMV Immunoglobulin (IgG) positive lung transplant

    Positive CMV Immunoglobulin (IgG) measured by IU/ml

    Up to 1 year

Secondary Outcomes (6)

  • Graft Outcome status

    Up to 1 year

  • Number of dead participants

    Up to 1 year

  • Duration of CMV medication

    Up to 1 year

  • Number of patients with CMV-positive results

    Up to 1 year

  • Severity of CMV Disease

    Up to 1 year

  • +1 more secondary outcomes

Study Arms (1)

Prophylaxis guided by Cytomegalovirus-specific T cell Immunity

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

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Participants attending the Miami Transplant Institute.

You may qualify if:

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

You may not qualify if:

  • Negative CMV IgG prior transplant
  • Pregnant or breastfeeding women
  • HIV infected patients
  • Combined organ (e.g., lung-heart, lung-kidney) transplant candidates

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Miami

Miami, Florida, 33136, United States

RECRUITING

MeSH Terms

Conditions

Lung Diseases

Condition Hierarchy (Ancestors)

Respiratory Tract Diseases

Study Officials

  • Yoichiro Natori, MD

    University of Miami

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Yoichiro Natori, MD

CONTACT

3053556323yxn138@med.miami.edu

Lissett Moni

CONTACT

3053555418ltueros@med.miami.edu

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor of Clinical

Study Record Dates

First Submitted

July 2, 2024

First Posted

July 10, 2024

Study Start

July 3, 2024

Primary Completion (Estimated)

December 30, 2026

Study Completion (Estimated)

December 30, 2026

Last Updated

March 23, 2026

Record last verified: 2026-03

Data Sharing

IPD Sharing
Will not share

Locations

US(1)