NCT02076971

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

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 92 (actual)
• Sponsor: Fundacio Catalana de Pneumologia · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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®).

Conditions

• Cytomegalovirus Infections

Timeline

• Start date: 2014-01-01
• Primary completion: 2016-03-01
• Completion: 2016-03-01
• First posted: 2014-03-04
• Last updated: 2016-09-14

Locations

7 sites across 1 country: Spain