Cytomegalovirus-Specific Response Measured by QuantiFeron® and Overall Immunologic Response Measured by ImmuKnow® in Lung Transplant Patients CMV-positive
- Conditions
- Cytomegalovirus Infections
- Registration Number
- NCT02076971
- Lead Sponsor
- Fundacio Catalana de Pneumologia
- 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®).
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 92
- 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.
- 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.
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 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 up to 12 months from transplant Quantiferon® is assessed multiple times and it will be considered positive when first positive test is assessed.
Measurement of overall immune response by determination of the activity of CD4+ (cluster of differentiation 4) T cells up to 12 months from transplant InmunKnow® is assessed multiple times and it will be considered positive when first positive test is assessed.
Quantification of CMV viral replication in blood measured by PCR (polymerase chain reaction) up to 12 months from transplant PCR is assessed multiple times and it will be considered positive when first positive test is assessed.
- Secondary Outcome Measures
Name Time Method 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 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 Determination of glomerular filtration rate 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 Complete blood count (WBC count) and routine biochemistry up to 12 months from transplant Follow-up loss/death (if it occurs) up to 12 months from transplant
Trial Locations
- Locations (7)
Hospital Universitario Marqués de Valdecilla
🇪🇸Santander, Cantabria, Spain
Hospital Universitario Puerta de Hierro Majadahonda
🇪🇸Majadahonda, Madrid, Spain
Hospital Vall d'Hebrón
🇪🇸Barcelona, Spain
Hospital Universitario y Politécnico la Fe
🇪🇸Valencia, Spain
Hospital Universitario A Coruña
🇪🇸A Coruña, Spain
Hospital Universitario 12 de Octubre
🇪🇸Madrid, Spain
Hospital Universitario Reina Sofía
🇪🇸Córdoba, Spain