Recruiting

Cytomegalovirus Prophylaxis

Sponsor:

University of Miami

Code:

NCT06494033

Conditions

Lung Diseases

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Lung Diseases

Study ID

NCT06494033

Start date

Jul 3, 2024

Status verified date

Mar, 2026

Completion date

Dec 30, 2026

Anticipated

Primary completion date

Dec 30, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

100 participants

Anticipated

Interventions and Outcome Measures

Arms

Prophylaxis guided by Cytomegalovirus-specific T cell Immunity

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

Primary outcome measure

  • Positive CMV Immunoglobulin (IgG) positive lung transplant [ Time Frame: Up to 1 year ]

Central Contacts and Locations

Central contacts

Yoichiro Natori, MD

3053556323yxn138@med.miami.edu

Lissett Moni

3053555418ltueros@med.miami.edu

Locations

University of Miami

Recruiting

Miami, Florida, United States, 33136

Contacts

Yoichiro Natori, MD

3053556323yxn138@med.miami.edu

Lissett Moni

3053555418ltueros@med.miami.edu

Principal Investigator:

Yoichiro Natori, MD

More Information

Sponsor

University of Miami

Last update posted

Mar 23, 2026

Last verified

Mar, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Miami on 2026-03-23.