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

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

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®).

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.