Cytomegalovirus-Specific Response Measured by QuantiFeron® and Overall Immunologic Response Measured by ImmuKnow® in Lung Transplant Patients CMV-positive

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine the sensitivity and specificity of QuantiFeron® and ImmuKnow® in combination for early detection of patients who will develop CMV infection in lung transplant patients with CMV-positive serology (R+) prior to transplant.

Detailed Description
-----------------
The secondary objectives of the study are: To evaluate Cytomegalovirus (CMV)-specific immune response measured by QuantiFeron®. To evaluate overall immune response measured by ImmuKnow®. To study the course of QuantiFeron® and ImmuKnow®over the follow-up period. To correlate levels of ImmuKnow® and QuantiFeron®. To evaluate the relationship between levels and doses of immunosuppressants and their relationship to degree of overall immunosuppression (ImmuKnow®). To evaluate the relationship between infections, immunological complications and degree of overall immunosuppression (ImmuKnow®).

Official Title
-----------------
A Multicenter Prospective Observational Study to Evaluate Cytomegalovirus (CMV)-Specific Response Measured by QuantiFeron® and Overall Immunologic Response Measured by ImmuKnow® in Lung Transplant Patients With CMV-positive Serology (R+) Prior to Transplant and Its Involvement in the Development of CMV Infection

Conditions
-----------------
Cytomegalovirus Infections

Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients aged ≥ 18 years. Men or women who have received a lung transplant. CMV-seropositive patients (R+). Patients who have been informed of the study procedures and have signed the informed consent form. Over 3 months posttransplant. Exclusion Criteria: Patients who are not expected to be able to be followed during the first 12 months posttransplant. Patient participation in another clinical trial or study will not be a criterion for exclusion.

Ages Eligible for Study
-----------------
Minimum Age: 18 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------
What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Quantification of interferon-γ produced by specific CD8+ (cluster of differentiation 8) T cells after ex-vivo stimulation with various CMV epitopes using the commercial assay QuantiFeron®- CMV | Quantiferon® is assessed multiple times and it will be considered positive when first positive test is assessed. | up to 12 months from transplant | 
| Measurement of overall immune response by determination of the activity of CD4+ (cluster of differentiation 4) T cells | InmunKnow® is assessed multiple times and it will be considered positive when first positive test is assessed. | up to 12 months from transplant | 
| Quantification of CMV viral replication in blood measured by PCR (polymerase chain reaction) | PCR is assessed multiple times and it will be considered positive when first positive test is assessed. | up to 12 months from transplant | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Measurement of immunosuppressive drugs: Blood levels of calcineurin inhibitors (tacrolimus or cyclosporine). Mycophenolate (or equivalent) dose and corticosteroid doses. |  | up to 12 months from transplant | 
| Complete blood count (WBC count) and routine biochemistry |  | up to 12 months from transplant | 
| Determination of glomerular filtration rate |  | up to 12 months from transplant | 
| Course of graft function by measuring GFR (glomerular filtration rate) |  | up to 12 months from transplant | 
| Complications since last visit: Infections, rejection episodes, chronic graft dysfunction, other complications |  | up to 12 months from transplant | 
| CMV prophylaxis, drug and dosage. Serious Adverse events related or no related to the drug |  | up to 12 months from transplant | 
| Follow-up loss/death (if it occurs) |  | up to 12 months from transplant | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Lung transplant, Quantiferon, Immuknow