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

Fundacio Catalana de Pneumologia

Status: Completed

Conditions: Cytomegalovirus Infections

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT02076971

FUN-CMV-2013-01

Details and patient eligibility

About

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.

Full 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®).

Enrollment: 92 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.