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NCT Number: NCT06494033

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

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.

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Key information

Conditions

Lung Diseases Respiratory Tract Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Miami

Miami, Florida, 33136, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Positive CMV Immunoglobulin (IgG) positive lung transplant

    Time frame: Up to 1 year

    Positive CMV Immunoglobulin (IgG) measured by IU/ml

Secondary outcomes

  1. Graft Outcome status

    Time frame: 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

  2. Number of dead participants

    Time frame: Up to 1 year

    Number of dead participants measured by numbers of death

  3. Duration of CMV medication

    Time frame: Up to 1 year

    Duration of CMV medication measured by treatment days

  4. Number of patients with CMV-positive results

    Time frame: Up to 1 year

    CMV disease measured by the number of patients with CMV-positive results

  5. Severity of CMV Disease

    Time frame: Up to 1 year

    Severity of CMV disease measured by CMV polymerase chain reaction (PCR) (IU/mL)

  6. Severity of Torque Teno virus

    Time frame: Up to 1 year

    Severity of Torque Teno virus measured by Torque Teno virus (TTV) (BAU/ml)

Interested in participating?

Recruiting

Interested in participating?

Request Info

Sponsors and collaborators

Lead sponsor

University of Miami

Other

Collaborators

  • Eurofins Viracor

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2026
Study completion
2026
First posted
Jul 10, 2024
Registry last updated
Mar 23, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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