Cytomegalovirus Infections
Conditions
Keywords
Lung transplant, Quantiferon, Immuknow
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®).
Interventions
None listed
Sponsors
Roche Farma, S.A
Fundacio Catalana de Pneumologia
Study design
Observational model
CASE_ONLY
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame |
|---|---|
| Determination of 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 |
| Course of graft function by measuring GFR (glomerular filtration rate) | up to 12 months from transplant |
| Follow-up loss/death (if it occurs) | 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 |
| 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 |
| Complete blood count (WBC count) and routine biochemistry | up to 12 months from transplant |
Countries
Spain
Outcome results
None listed