Clinical trial NCT02076971: Cytomegalovirus-Specific Response Measured by QuantiFeron® and Overall Immunologic Response Measured by ImmuKnow® in Lung Transplant Patients CMV-positive
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Cytomegalovirus Infections
Keywords: Lung transplant
Quantiferon
Immuknow
Lead sponsor: Fundacio Catalana de Pneumologia
Sponsor class: OTHER
Collaborators: name: Roche Farma, S.A
First posted: 2014-03-04
Enrollment: 92
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: CMV-positive (R+) lung transplant patients

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®).

Eligibility criteria: 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.

Primary outcomes:
measure: 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
timeFrame: up to 12 months from transplant
measure: Measurement of overall immune response by determination of the activity of CD4+ (cluster of differentiation 4) T cells
timeFrame: up to 12 months from transplant
measure: Quantification of CMV viral replication in blood measured by PCR (polymerase chain reaction)
timeFrame: up to 12 months from transplant
Secondary outcomes:
measure: Measurement of immunosuppressive drugs: Blood levels of calcineurin inhibitors (tacrolimus or cyclosporine). Mycophenolate (or equivalent) dose and corticosteroid doses.
timeFrame: up to 12 months from transplant
measure: Complete blood count (WBC count) and routine biochemistry
timeFrame: up to 12 months from transplant
measure: Determination of glomerular filtration rate
timeFrame: up to 12 months from transplant
measure: Course of graft function by measuring GFR (glomerular filtration rate)
timeFrame: up to 12 months from transplant
measure: Complications since last visit: Infections, rejection episodes, chronic graft dysfunction, other complications
timeFrame: up to 12 months from transplant
measure: CMV prophylaxis, drug and dosage. Serious Adverse events related or no related to the drug
timeFrame: up to 12 months from transplant
measure: Follow-up loss/death (if it occurs)
timeFrame: up to 12 months from transplant
Other outcomes:
Locations:
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Majadahonda
country: Spain
facility: Hospital Universitario Puerta de Hierro Majadahonda
state: Madrid
city: A Coruña
country: Spain
facility: Hospital Universitario A Coruña
city: Barcelona
country: Spain
facility: Hospital Vall d'Hebrón
city: Córdoba
country: Spain
facility: Hospital Universitario Reina Sofía
city: Madrid
country: Spain
facility: Hospital Universitario 12 de Octubre
city: Valencia
country: Spain
facility: Hospital Universitario y Politécnico la Fe
Study officials:
affiliation: Hospital Vall d'Hebron
name: Victor Monforte, MD
role: STUDY_CHAIR
affiliation: Hospital Puerta de Hierro
name: Piedad Ussetti, MD
role: STUDY_CHAIR
affiliation: Hospital Vall d'Hebron Laboratory
name: Susana Gómez, MD
role: STUDY_CHAIR
affiliation: Hospital Vall d'Hebrón
name: Victor Monforte, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Puerta Hierro
name: Piedad Ussetti, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Reina Sofía
name: Francisco Santos, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Marqués de Valdecilla
name: José Cifrián, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario A Coruña
name: José M Borro, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital 12 de Octubre
name: Virginia Pérez, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitario La Fe
name: Amparo Solé, MD
role: PRINCIPAL_INVESTIGATOR
References: