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

Cytomegalovirus Infections Clinical Trial

— REIVI  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02076971
• Other study ID #: FUN-CMV-2013-01
• Status: Completed
• Phase: N/A
• First received: February 27, 2014
• Last updated: September 13, 2016
• Start date: January 2014
• Est. completion date: March 2016

Study information

• Verified date: September 2016
• Source: Fundacio Catalana de Pneumologia
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Observational

Clinical Trial 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.

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®).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 92
• Est. completion date: March 2016
• Est. primary completion date: March 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cytomegalovirus Infections
• Infection

Locations

Country	Name	City	State
Spain	Hospital Universitario A Coruña	A Coruña
Spain	Hospital Vall d'Hebrón	Barcelona
Spain	Hospital Universitario Reina Sofía	Córdoba
Spain	Hospital Universitario 12 de Octubre	Madrid
Spain	Hospital Universitario Puerta de Hierro Majadahonda	Majadahonda	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital Universitario y Politécnico la Fe	Valencia

Sponsors (2)

Lead Sponsor	Collaborator
Fundacio Catalana de Pneumologia	Roche Farma, S.A

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Quantification of interferon-? 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	No
Primary	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	No
Primary	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	No
Secondary	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	No
Secondary	Complete blood count (WBC count) and routine biochemistry		up to 12 months from transplant	No
Secondary	Determination of glomerular filtration rate		up to 12 months from transplant	No
Secondary	Course of graft function by measuring GFR (glomerular filtration rate)		up to 12 months from transplant	No
Secondary	Complications since last visit: Infections, rejection episodes, chronic graft dysfunction, other complications		up to 12 months from transplant	No
Secondary	CMV prophylaxis, drug and dosage. Serious Adverse events related or no related to the drug		up to 12 months from transplant	No
Secondary	Follow-up loss/death (if it occurs)		up to 12 months from transplant	No