CompletedNot Applicable

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

Spain92 participantsStarted 2014-01

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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

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

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

Timeframe: up to 12 months from transplant

Trial details

NCT IDNCT02076971

SponsorFundacio Catalana de Pneumologia

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2016-03

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