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

Prophylaxis Guided by Cytomegalovirus-specific T Cell Immunity to Prevent Cytomegalovirus Disease in Lung Transplant Recipients: a Single Center Prospective Study

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT06494033

Enrollment

100

Registered

2024-07-10

Start date

2024-07-03

Completion date

2026-12-30

Last updated

2026-03-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Lung Diseases

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Positive CMV Immunoglobulin (IgG) positive lung transplant	Up to 1 year	Positive CMV Immunoglobulin (IgG) measured by IU/ml

Secondary

Measure	Time frame	Description
Graft Outcome status	Up to 1 year	Graft Outcome status measured by number of rejection based on forced expiratory volume in 1 second( FEV1) /Forced vital capacity (FVC) ratio. A calculated ratio that helps diagnose obstructive and restrictive lung diseases
Number of dead participants	Up to 1 year	Number of dead participants measured by numbers of death
Duration of CMV medication	Up to 1 year	Duration of CMV medication measured by treatment days
Number of patients with CMV-positive results	Up to 1 year	CMV disease measured by the number of patients with CMV-positive results
Severity of CMV Disease	Up to 1 year	Severity of CMV disease measured by CMV polymerase chain reaction (PCR) (IU/mL)
Severity of Torque Teno virus	Up to 1 year	Severity of Torque Teno virus measured by Torque Teno virus (TTV) (BAU/ml)

Countries

United States

Contacts

CONTACTYoichiro Natori, MD

yxn138@med.miami.edu3053556323

CONTACTLissett Moni

ltueros@med.miami.edu3053555418

PRINCIPAL_INVESTIGATORYoichiro Natori, MD

University of Miami

Outcome results