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

Recruiting

• Conditions: Lung Diseases

• Registration Number: NCT06494033
• Lead Sponsor: University of Miami

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2024-07-02
• Study First Submitted QC: 2024-07-02
• Study First Posted: 2024-07-10
• Status Verified: 2024-12
• Study Start: 2024-12-03
• Last Update Submitted: 2025-03-21
• Last Update Posted: 2025-03-26
• Primary Completion: 2026-06-30
• Study Completion: 2026-06-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 100

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

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Positive CMV Immunoglobulin (IgG) positive lung transplant	Up to 1 year	Positive CMV Immunoglobulin (IgG) measured by IU/ml

Secondary Outcome Measures

Name	Time	Method
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)

Trial Locations

Locations (1)

University of Miami; 🇺🇸 Miami, Florida, United States