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

ConditionLung Diseases
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorUniversity of Miami

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

Negative CMV IgG prior transplant

Pregnant or breastfeeding women

HIV infected patients

Combined organ (e.g., lung-heart, lung-kidney) transplant candidates

Trial population

Participants attending the Miami Transplant Institute.

Trial design

Design model

Cohort

Time perspective

Prospective

Treatments tested in this trial

Not listed

Trial groups

100 Participants
are grouped into 1 trial group
Group A: Prophylaxis guided by Cytomegalovirus-specific T cell Immunity

Trial outcomes

Primary outcomes

1

Positive CMV Immunoglobulin (IgG) positive lung transplant

Positive CMV Immunoglobulin (IgG) measured by IU/ml

Time frame
Up to 1 year

Secondary outcomes

1

Graft Outcome status

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

Time frame
Up to 1 year
2

Number of dead participants

Number of dead participants measured by numbers of death

Time frame
Up to 1 year
3

Duration of CMV medication

Duration of CMV medication measured by treatment days

Time frame
Up to 1 year
4

Number of patients with CMV-positive results

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

Time frame
Up to 1 year

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Miami

Lead sponsor

Eurofins Viracor

Collaborator