Cytomegalovirus InfectionsREIVINCT02076971
Cytomegalovirus-Specific Response Measured by QuantiFeron® and Overall Immunologic Response Measured by ImmuKnow® in Lung Transplant Patients CMV-positive
An observational study of Cytomegalovirus Infections, run by Fundacio Catalana de Pneumologia at 7 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cytomegalovirus Infections
- How many people
- 92 participants
- Where
- 7 sitesSpain
- Study dates
- Jan 2014to Mar 2016
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: CMV-positive (R+) lung transplant patients
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Hospital Universitario A Coruña
A Coruña, A Coruña, 15006
Hospital Vall d'Hebrón
Barcelona, 08035
Hospital Universitario Reina Sofía
Córdoba, Córdoba, 14004
Hospital Universitario 12 de Octubre
Madrid, Madrid, 28041
Hospital Universitario Puerta de Hierro Majadahonda
Majadahonda, Madrid, 28222
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, 39008
Hospital Universitario y Politécnico la Fe
Valencia, Valencia, 46026
About this study
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
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
- Cytomegalovirus Infections
- Keywords
- Lung transplant, Quantiferon, Immuknow
- Medical subject headings
- Cytomegalovirus Infections
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: up to 12 months from transplant
Secondary outcomes (7)
Measurement of immunosuppressive drugs: Blood levels of calcineurin inhibitors (tacrolimus or cyclosporine). Mycophenolate (or equivalent) dose and corticosteroid doses.
Measured: up to 12 months from transplant
Complete blood count (WBC count) and routine biochemistry
Measured: up to 12 months from transplant
Determination of glomerular filtration rate
Measured: up to 12 months from transplant
Course of graft function by measuring GFR (glomerular filtration rate)
Measured: up to 12 months from transplant
Complications since last visit: Infections, rejection episodes, chronic graft dysfunction, other complications
Measured: up to 12 months from transplant
CMV prophylaxis, drug and dosage. Serious Adverse events related or no related to the drug
Measured: up to 12 months from transplant
Follow-up loss/death (if it occurs)
Measured: up to 12 months from transplant
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2014 (estimated)
- Study startJan 2014
- Primary completionMar 2016
- Study completionMar 2016
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cytomegalovirus InfectionsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio Catalana de Pneumologia
- Sponsor type
- University, hospital or other
- Collaborators
- Roche Farma, S.A
- Responsible party
- Principal investigator, Victor Monforte, Fundacio Catalana de Pneumologia
- Investigators
- Victor Monforte, MD, Study chair, Hospital Vall d'HebronPiedad Ussetti, MD, Study chair, Hospital Puerta de HierroSusana Gómez, MD, Study chair, Hospital Vall d'Hebron LaboratoryVictor Monforte, MD, Principal investigator, Hospital Vall d'HebrónPiedad Ussetti, MD, Principal investigator, Hospital Puerta HierroFrancisco Santos, MD, Principal investigator, Hospital Reina SofíaJosé Cifrián, MD, Principal investigator, Hospital Marqués de ValdecillaJosé M Borro, MD, Principal investigator, Hospital Universitario A Coruña
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02076971
- Sponsor's protocol ID
- FUN-CMV-2013-01
- Acronym
- REIVI
- Status last verified
- Sep 2016
- First submitted
- 27 Feb 2014
- Last updated
- 14 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT02076971
- Acronym / sponsor ID
- REIVI / FUN-CMV-2013-01
- Conditions
- Cytomegalovirus Infections
- Keywords
- Lung transplant, Quantiferon, Immuknow
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- Fundacio Catalana de PneumologiaUniversity, hospital or other
- Collaborators
- Roche Farma, S.A
- Study start
- Jan 2014
- Primary completion
- Mar 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 4 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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®).
Study design
- Observational model
- Case only
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- CMV-positive (R+) lung transplant patients
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
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.
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.
7 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
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
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cytomegalovirus Infections, run by Fundacio Catalana de Pneumologia at 7 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2016.