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

N/ACompletedNCT02076971

Fundacio Catalana de Pneumologia92 enrolled

Overview

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.

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®).

Study Type

OBSERVATIONAL

Enrollment

Conditions

Cytomegalovirus Infections

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (7)

Hospital Universitario A Coruña

A Coruña, A Coruña, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Outcomes

Primary Outcomes

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.