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Recruiting NCT06494033

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

Observational Lung Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Lung Diseases. Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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.

Primary outcome measures

  • Positive CMV Immunoglobulin (IgG) positive lung transplant [Time frame: Up to 1 year]
Secondary outcome measures (6)
  • Graft Outcome status [Time frame: Up to 1 year]
  • Number of dead participants [Time frame: Up to 1 year]
  • Duration of CMV medication [Time frame: Up to 1 year]
  • Number of patients with CMV-positive results [Time frame: Up to 1 year]
  • Severity of CMV Disease [Time frame: Up to 1 year]
  • Severity of Torque Teno virus [Time frame: Up to 1 year]

Eligibility criteria

Inclusion criteria

  • 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)

Exclusion criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United States · 1 center
  • University of Miami — Miami

Identifiers

NCT: NCT06494033 · 20230432

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗