Cytomegalovirus-Specific Response Measured by QuantiFeron® and Overall Immunologic Response Measured by ImmuKnow® in Lung Transplant Patients CMV-positive

NCT02076971 | Completed

• 1 other identifier: FUN-CMV-2013-01
• Study Type: observational
• Target: 92
• Locations: 1 country
• Sites: 7

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.

Conditions

Cytomegalovirus Infections

Keywords

Lung transplant; Quantiferon; Immuknow

Outcome Measures

Primary Outcomes (3)

• 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

Secondary Outcomes (7)

• 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

• 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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

CMV-positive (R+) lung transplant patients

You may qualify if:

• 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.

You may not qualify if:

• Patients who are not expected to be able to be followed during the first 12 months posttransplant.

Sponsors & Collaborators

• Fundacio Catalana de Pneumologia: lead
• Roche Farma, S.A: collaborator

Study Sites (7)

Hospital Universitario A Coruña

A Coruña, A Coruña, 15006, Spain

Location

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario Reina Sofía

Córdoba, Córdoba, 14004, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, Madrid, 28041, Spain

Location

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, 28222, Spain

Location

Hospital Universitario y Politécnico la Fe

Valencia, Valencia, 46026, Spain

Location

Hospital Vall d'Hebrón

Barcelona, 08035, Spain

Location

Biospecimen

Retention: NONE RETAINED

Whole blood

MeSH Terms

Conditions

Cytomegalovirus Infections

Condition Hierarchy (Ancestors)

Herpesviridae Infections; DNA Virus Infections; Virus Diseases; Infections

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Hospital Vall d'Hebron

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 4, 2014
• Study Start: January 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: September 14, 2016

Record last verified: 2016-09

Locations

ES (7)