CompletedNCT02076971REIVIUpdated Sep 14, 2016

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

An observational study in Cytomegalovirus Infections, sponsored by Fundacio Catalana de Pneumologia. Completed at 7 sites in Spain. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2016-09-14.

Sponsored by Fundacio Catalana de Pneumologia · Observational

Study type: Observational
Model: Case-only
Time perspective: Prospective
Enrollment: 92
Ages: 18 Years and older
Sex: All

Study 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.

Read the 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 studied

Cytomegalovirus Infections

Browse trials for

Cytomegalovirus Infections 362

Keywords

Lung transplant
Quantiferon
Immuknow

In context

Cytomegalovirus Infections

362 studies on the registry are indexed under Cytomegalovirus Infections; 59 are open to participants now.

This study's enrollment of 92 is below the median of 150 across 100 observational studies indexed under Cytomegalovirus Infections.

Browse Cytomegalovirus Infections studies →

Lead sponsor

Fundacio Catalana de Pneumologia is the lead sponsor of 3 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No
Sampling method: Probability sample

Study population

CMV-positive (R+) lung transplant patients

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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
Enrollment: 92 participants (actual)
Patient registry: No
Biospecimen retention: None retained

What researchers measure

Primary outcomes

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.
Time frame: 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.
Time frame: 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.
Time frame: up to 12 months from transplant

Secondary outcomes

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

Study locations

7 sites

Hospital Universitario A Coruña
A Coruña, A Coruña 15006, Spain
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria 39008, Spain
Hospital Universitario Reina Sofía
Córdoba, Córdoba 14004, Spain
Hospital Universitario 12 de Octubre
Madrid, Madrid 28041, Spain
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid 28222, Spain
Hospital Universitario y Politécnico la Fe
Valencia, Valencia 46026, Spain
Hospital Vall d'Hebrón
Barcelona, 08035, Spain

Timeline

Tracking since Sep 25, 2026

Not marked actual or estimatedDates not marked actual or estimated

The record gives a start of Jan 2014, a primary completion of Mar 2016 and a completion of Mar 2016. It does not say whether these dates are actual or estimated.

How these figures are worked out, and which studies are left out of them.

Registered: Feb 27, 2014
First posted: Mar 4, 2014
Start: Jan 2014
Primary completionActual: Mar 2016
CompletionActual: Mar 2016
Last update: Sep 14, 2016

What these dates mean

Start.: When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.: When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.: When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.: Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.

No changes since tracking began. The registry record was last updated on Sep 14, 2016, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT02076971
Lead sponsor: Fundacio Catalana de Pneumologia
Collaborators: Roche Farma, S.A
Responsible party: Victor Monforte (Hospital Vall d'Hebron, Fundacio Catalana de Pneumologia) — Principal investigator
First posted: Mar 4, 2014
Start date: Jan 2014
Primary completion: Mar 2016
Completion: Mar 2016
Last update: Sep 14, 2016

Study contacts

Victor Monforte, MD

study chair · Hospital Vall d'Hebron

Piedad Ussetti, MD

study chair · Hospital Puerta de Hierro

Susana Gómez, MD

study chair · Hospital Vall d'Hebron Laboratory

Victor Monforte, MD

principal investigator · Hospital Vall d'Hebrón

Piedad Ussetti, MD

principal investigator · Hospital Puerta Hierro

Francisco Santos, MD

principal investigator · Hospital Reina Sofía

José Cifrián, MD

principal investigator · Hospital Marqués de Valdecilla

José M Borro, MD

principal investigator · Hospital Universitario A Coruña

Virginia Pérez, MD

principal investigator · Hospital 12 de Octubre

Amparo Solé, MD

principal investigator · Hospital Universitario La Fe

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Sep 2016. You cannot join it, but the record below documents what was studied.

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Discussion

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