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| Name | Class |
|---|---|
| Roche Farma, S.A | INDUSTRY |
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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:
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| Measure | Description | Time Frame |
|---|---|---|
| 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 | Quantiferon® is assessed multiple times and it will be considered positive when first positive test is assessed. | up to 12 months from transplant |
| Measurement of overall immune response by determination of the activity of CD4+ (cluster of differentiation 4) T cells | InmunKnow® is assessed multiple times and it will be considered positive when first positive test is assessed. | up to 12 months from transplant |
| Quantification of CMV viral replication in blood measured by PCR (polymerase chain reaction) | PCR is assessed multiple times and it will be considered positive when first positive test is assessed. | up to 12 months from transplant |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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CMV-positive (R+) lung transplant patients
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| Name | Affiliation | Role |
|---|---|---|
| Victor Monforte, MD | Hospital Vall d'Hebron | Study Chair |
| Piedad Ussetti, MD | Hospital Puerta de Hierro | Study Chair |
| Susana Gómez, MD | Hospital Vall d'Hebron Laboratory | Study Chair |
| Victor Monforte, MD | Hospital Vall d'Hebrón | Principal Investigator |
| Piedad Ussetti, MD | Hospital Puerta Hierro | Principal Investigator |
| Francisco Santos, MD | Hospital Reina Sofía | Principal Investigator |
| José Cifrián, MD | Hospital Marqués de Valdecilla | Principal Investigator |
| José M Borro, MD | Hospital Universitario A Coruña | Principal Investigator |
| Virginia Pérez, MD | Hospital 12 de Octubre | Principal Investigator |
| Amparo Solé, MD | Hospital Universitario La Fe |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Universitario A Coruña | A Coruña | A Coruña | 15006 | Spain | ||
| Hospital Universitario Marqués de Valdecilla |
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Whole blood
| up to 12 months from transplant |
| Determination of glomerular filtration rate | up to 12 months from transplant |
| 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 |
| CMV prophylaxis, drug and dosage. Serious Adverse events related or no related to the drug | up to 12 months from transplant |
| Follow-up loss/death (if it occurs) | up to 12 months from transplant |
| Principal Investigator |
| Santander |
| Cantabria |
| 39008 |
| Spain |
| Hospital Universitario Reina Sofía | Córdoba | Córdoba | 14004 | Spain |
| Hospital Universitario 12 de Octubre | Madrid | Madrid | 28041 | Spain |
| Hospital Universitario Puerta de Hierro Majadahonda | Majadahonda | Madrid | 28222 | Spain |
| Hospital Universitario y Politécnico la Fe | Valencia | Valencia | 46026 | Spain |
| Hospital Vall d'Hebrón | Barcelona | 08035 | Spain |
| ID | Term |
|---|---|
| D003586 | Cytomegalovirus Infections |
| ID | Term |
|---|---|
| D006566 | Herpesviridae Infections |
| D004266 | DNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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