Skip to main content
OpenTrials
Completed

NCT Number: NCT02076971

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Cytomegalovirus Infections DNA Virus Infections Herpesviridae Infections Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital Universitario A Coruña, A Coruña, Spain

Loading trial locations.

About this study

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®).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. 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

    Time frame: up to 12 months from transplant

    Quantiferon® is assessed multiple times and it will be considered positive when first positive test is assessed.

  2. Measurement of overall immune response by determination of the activity of CD4+ (cluster of differentiation 4) T cells

    Time frame: up to 12 months from transplant

    InmunKnow® is assessed multiple times and it will be considered positive when first positive test is assessed.

  3. Quantification of CMV viral replication in blood measured by PCR (polymerase chain reaction)

    Time frame: up to 12 months from transplant

    PCR is assessed multiple times and it will be considered positive when first positive test is assessed.

Secondary outcomes

  1. Measurement of immunosuppressive drugs: Blood levels of calcineurin inhibitors (tacrolimus or cyclosporine). Mycophenolate (or equivalent) dose and corticosteroid doses.

    Time frame: up to 12 months from transplant

  2. Complete blood count (WBC count) and routine biochemistry

    Time frame: up to 12 months from transplant

  3. Determination of glomerular filtration rate

    Time frame: up to 12 months from transplant

  4. Course of graft function by measuring GFR (glomerular filtration rate)

    Time frame: up to 12 months from transplant

  5. Complications since last visit: Infections, rejection episodes, chronic graft dysfunction, other complications

    Time frame: up to 12 months from transplant

  6. CMV prophylaxis, drug and dosage. Serious Adverse events related or no related to the drug

    Time frame: up to 12 months from transplant

  7. Follow-up loss/death (if it occurs)

    Time frame: up to 12 months from transplant

Sponsors and collaborators

Lead sponsor

Fundacio Catalana de Pneumologia

Other

Collaborators

  • Roche Farma, S.A

Registry information

Official study 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

Acronym: REIVI

Important dates

Study start
2014
Primary completion
2016
Study completion
2016
First posted
Mar 4, 2014
Registry last updated
Sep 14, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.