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

NCT ID: NCT02076971

Last Updated: 2016-09-14

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 92 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2014-01-31
• Study Completion Date: 2016-03-31

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®).

Conditions

Cytomegalovirus Infections

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Roche Farma, S.A

INDUSTRY

Sponsor Role: collaborator

Fundacio Catalana de Pneumologia

OTHER

Sponsor Role: lead

Responsible Party

Victor Monforte

Hospital Vall d'Hebron

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Victor Monforte, MD

Role: STUDY_CHAIR

Hospital Vall d'Hebron

Piedad Ussetti, MD

Role: STUDY_CHAIR

Hospital Puerta de Hierro

Susana Gómez, MD

Role: STUDY_CHAIR

Hospital Vall d'Hebron Laboratory

Victor Monforte, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Vall d'Hebrón

Piedad Ussetti, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Puerta Hierro

Francisco Santos, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Reina Sofía

José Cifrián, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Marqués de Valdecilla

José M Borro, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario A Coruña

Virginia Pérez, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital 12 de Octubre

Amparo Solé, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitario La Fe

Locations

Hospital Universitario A Coruña

A Coruña, A Coruña, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Reina Sofía

Córdoba, Córdoba, Spain

Hospital Universitario 12 de Octubre

Madrid, Madrid, Spain

Hospital Universitario Puerta de Hierro Majadahonda

Majadahonda, Madrid, Spain

Hospital Universitario y Politécnico la Fe

Valencia, Valencia, Spain

Hospital Vall d'Hebrón

Barcelona, , Spain

Countries

Spain

Other Identifiers

FUN-CMV-2013-01

Identifier Type: -

Identifier Source: org_study_id