Heart Transplant InfectionPhase 4ELISPOT-TCNCT04278547
Multicenter Clinical Trial to Evaluate the Efficacy of a Preventive Strategy Against CMV Infection in Heart Transplant Patients, Based on the Specific T Cells Response
A Phase 4 study testing ELISPOT IFN-γ assay in people with Heart Transplant Infection and CMV Infection, run by Hospital Universitari de Bellvitge at 1 site in Spain.
Trial summary
This study evaluates the efficacy and safety of an individualized preventive strategy against CMV infection in CMV seropositive heart transplant patients based on the specific basal response of the lymphocytes againts CMV (ELISPOT Interferon-γ assay). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Transplant Infection, CMV Infection
- What is being tested?
- ELISPOT IFN-γ assay
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 188 participants
- Where
- 1 siteSpain
- Study dates
- 12 Jun 2020to 25 Mar 2023
- Phase
- Phase 4
- 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
Who may be able to join
- Adult patients (18 years or more), both sexes, heart transplant patients.
- Patients with positive IgG against CMV (seropositive).
- Informed consent given by the subject or his legal representative.
- Availability of obtaining recipient and donor serologies.
- Availability of obtaining biological samples of peripheral blood post-transplant to be able to perform the ELISPOT IFN-γ assay.
- Women of childbearing age who use effective contraceptive measures during and until, so less, 30 days after treatment. Men who use contraceptive measures of barrier during and for at least 90 days after treatment, unless there is certainty that the female partner does not run the risk of becoming pregnant.
Who cannot join
- Pregnancy and / or breastfeeding period.
- Patients with contraindication for the use of valganciclovir or ganciclovir.
- Patients receiving thymoglobulin as induction therapy.
Trial locations and contacts
1 site in 1 country.
Elena García Romero contact
Spain1 site, 1 recruiting
- Recruiting
Hospital Universitari de Bellvitge
Barcelona, 08907
Jose González Costello, jgonzalez@bellvitgehospital.cat
Elena García Romero
About this study
Official title: Phase IV Clinical Trial, Open, Randomized, Controlled and Multicentric, With Two Parallel Groups, to Assess the Efficacy of a Preventive Strategy Against Cytomegalovirus Infection in Heart Transplant Patients, Based on the Specific Basal T Cell Response Against Cytomegalovirus: ELISPOT-TC
This study evaluates the efficacy and safety of an individualized preventive strategy against CMV infection in CMV seropositive heart transplant patients based on the specific basal response of the lymphocytes againts CMV (ELISPOT Interferon-γ assay).
In two thirds of the patients a preventive strategy will be carried out based on the result of the ELISPOT IFN-γ assay and in one third of the patients the standard of care strategy will be carried out (universal prophylaxis).
Read the detailed description
Background: The prevention of Cytomegalovirus (CMV) infection in cardiac transplant patients is currently based exclusively on the performance of the serotypes of the receptor and the donor. Despite prophylactic treatment with valganciclovir or preemptive therapy through serial monitoring of blood viral copies, the rate of infection or CMV disease remains high and has a negative clinical impact. The evaluation of the specific T lymphocytes cellular immune response against 2 CMV antigens prior to kidney transplantaction, using the ELISPOT IFN-γ assay discriminates in a better way which patients will develop CMV infection.
Objetives: To compare the cumulative incidence of CMV infection during the first year post-heart transplant amongst CMV seropositive recipients in 12 national centers, where the prophylactic strategy regarding CMV infection will be guided by the ELISPOT IFN-γ assay or not (control). Main variable: number of patients who have CMV infection in the first year post-trasplant (HT).
Hyphotesis: A preventive strategy against CMV infection in CMV seropositive heart transplant patients, based on the specific basal response of the T lymphocytes against CMV, ELISPOT IFN-γ assay, is effective, safe and not inferior than the control group in terms of infection CMV rates. Design: The investigators propose a phase IV clinical trial (with authorized treatment), randomized (2:1), controlled, open label and multicentric, with two parallel groups (Experimental group: preventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis; Control group: Standard of care, universal prophylaxis with valgancyclovir for 3 months).
Follow-up: 1 year. Duration of the trial: 3 years. Sample size: 188 patients.
- Conditions
- Heart Transplant Infection, CMV Infection
- Being tested
- ELISPOT IFN-γ assay
- Medical subject headings
- Cytomegalovirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ELISPOT IFN-γ assayDiagnostic test
Also called Valganciclovir
ELISPOT IFN-γ diagnostic test: Evaluation of specific cellular immune response against the IE-1 antigen and the CMV pp65, using the technique ELISPOT IFN-γ and individualize the preventive strategy according to the result. In patients with a ELISPOT of "low risk" will be made advance therapy (preemptive therapy) guided by PCR of CMV In patients with a "high risk" ELISPOT, universal prophylaxis with valganciclovir will be performed oral (900 mg / 24h) or intravenous ganciclovir (5-10 mg / Kd / day) in case the oral route is not available.
| Study group | Role | What they receive |
|---|---|---|
| Experimental group | Experimental | Preventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis; Receives: Diagnostic Test: ELISPOT IFN-γ assay |
| Control group | No intervention | Standard of care, universal prophylaxis with valgancyclovir for 3 months). |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients who have CMV infection in the first year post heart transplant.
Any viremia
Measured: One year
Secondary outcomes (20)
Number of patients with late CMV infection.
Number of patients with late CMV infection who have received prophylaxis with valganciclovir or ganciclovir (group 1 a and control group), once the treatment is finished.
Measured: One year
Number of patients with acute rejection.
Measured: One year
Number of patients with vascular graft disease.
Measured: One year
Number of patients with other bacterial or viral opportunistic infections.
Measured: One year
Number of patients with leukopenia secondary to prophylaxis.
Measured: One year
Number of patients with neutropenia secondary to prophylaxis.
Measured: One year
Number of leukopenia patients presenting with other bacterial infections or viral.
Measured: One year
Number of deceased patients during hospital admission post-heart transplant.
Measured: One year
Number of deceased patients, related to CMV infection, in the first year post-transplant.
Measured: One year
Number of deceased patients, related to CMV disease, in the first post-transplant year.
Measured: One year
Number of patients who died from any cause in the first year post-heart transplant.
Measured: One year
Title of specific Inmunoglobulin G antibodies against serum CMV.
Measured: One year
Title of nonspecific serum gammaglobulins.
Measured: One year
CMV-specific memory response B (ELISPOT B).
Measured: One year
Number of patients whose ELISPOT varies from low to intermediate or high risk.
Measured: One year
Number of patients whose ELISPOT varies from intermediate or high risk to low risk.
Measured: One year
Number of spots against the IE-1 antigen.
Measured: One year
Number of spots against the pp65 antigen.
Measured: One year
Number of copies of CMV DNA measured by polymerase chain reaction (PCR).
Measured: One year
Estimate the economic cost of both strategies studied in this clinical trial
Measured: One year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2020
- Study start12 Jun 2020
- Primary completion25 Mar 2022 (estimated)
- Study completion25 Mar 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Transplant InfectionStudies 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
- Interventional
- Phase
- Phase 4
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Phase IV clinical trial (with authorized treatment), randomized (2:1), controlled, open label and multicentric, with two parallel groups (Experimental group: preventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis; Control group: Standard of care, universal prophylaxis with valgancyclovir for 3 months).
- Masking
- None (open label)
- Enrolment
- 188 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hospital Universitari de Bellvitge
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Spanish Society of Cardiology
- Responsible party
- Principal investigator, Elena García Romero, Hospital Universitari de Bellvitge
- Investigators
- José González Costello, Principal investigator, Cardiologist
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04278547
- Sponsor's protocol ID
- PI19/01610
- Acronym
- ELISPOT-TC
- Status last verified
- Dec 2020
- First submitted
- 18 Feb 2020
- Last updated
- 23 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Clinical Trial, Open, Randomized, Controlled and Multicentric, With Two Parallel Groups, to Assess the Efficacy of a Preventive Strategy Against Cytomegalovirus Infection in Heart Transplant Patients, Based on the Specific Basal T Cell Response Against Cytomegalovirus: ELISPOT-TC
- ClinicalTrials.gov ID
- NCT04278547
- Acronym / sponsor ID
- ELISPOT-TC / PI19/01610
- Conditions
- Heart Transplant Infection, CMV Infection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 188 participants (estimated)
- Lead sponsor
- Hospital Universitari de BellvitgeUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Spanish Society of Cardiology
- Study start
- 12 Jun 2020 (actual)
- Primary completion
- 25 Mar 2022 (estimated)
- Study completion
- 25 Mar 2023 (estimated)
- First posted
- 20 Feb 2020 (actual)
- 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.
This study evaluates the efficacy and safety of an individualized preventive strategy against CMV infection in CMV seropositive heart transplant patients based on the specific basal response of the lymphocytes againts CMV (ELISPOT Interferon-γ assay).
In two thirds of the patients a preventive strategy will be carried out based on the result of the ELISPOT IFN-γ assay and in one third of the patients the standard of care strategy will be carried out (universal prophylaxis).
Detailed description
Background: The prevention of Cytomegalovirus (CMV) infection in cardiac transplant patients is currently based exclusively on the performance of the serotypes of the receptor and the donor. Despite prophylactic treatment with valganciclovir or preemptive therapy through serial monitoring of blood viral copies, the rate of infection or CMV disease remains high and has a negative clinical impact. The evaluation of the specific T lymphocytes cellular immune response against 2 CMV antigens prior to kidney transplantaction, using the ELISPOT IFN-γ assay discriminates in a better way which patients will develop CMV infection.
Objetives: To compare the cumulative incidence of CMV infection during the first year post-heart transplant amongst CMV seropositive recipients in 12 national centers, where the prophylactic strategy regarding CMV infection will be guided by the ELISPOT IFN-γ assay or not (control). Main variable: number of patients who have CMV infection in the first year post-trasplant (HT).
Hyphotesis: A preventive strategy against CMV infection in CMV seropositive heart transplant patients, based on the specific basal response of the T lymphocytes against CMV, ELISPOT IFN-γ assay, is effective, safe and not inferior than the control group in terms of infection CMV rates. Design: The investigators propose a phase IV clinical trial (with authorized treatment), randomized (2:1), controlled, open label and multicentric, with two parallel groups (Experimental group: preventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis; Control group: Standard of care, universal prophylaxis with valgancyclovir for 3 months).
Follow-up: 1 year. Duration of the trial: 3 years. Sample size: 188 patients.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Phase IV clinical trial (with authorized treatment), randomized (2:1), controlled, open label and multicentric, with two parallel groups (Experimental group: preventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis; Control group: Standard of care, universal prophylaxis with valgancyclovir for 3 months).
| Arm | Type | Receives |
|---|---|---|
| Experimental group | Experimental | Diagnostic Test: ELISPOT IFN-γ assayPreventive strategy based on the ELISPOT IFN-γ result: If patients are stratified as high risk they will receive prophylaxis with valgancyclovir for 3 months and if they are stratified as low risk they will be treated with preemptive therapy guided by CMV polymerase chain reaction analysis; |
| Control group | No intervention | –Standard of care, universal prophylaxis with valgancyclovir for 3 months). |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Adult patients (18 years or more), both sexes, heart transplant patients.
- Patients with positive IgG against CMV (seropositive).
- Informed consent given by the subject or his legal representative.
- Availability of obtaining recipient and donor serologies.
- Availability of obtaining biological samples of peripheral blood post-transplant to be able to perform the ELISPOT IFN-γ assay.
Key exclusion criteria (3 listed)
- Pregnancy and / or breastfeeding period.
- Patients with contraindication for the use of valganciclovir or ganciclovir.
- Patients receiving thymoglobulin as induction therapy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ELISPOT IFN-γ assayAlso: ValganciclovirELISPOT IFN-γ diagnostic test: Evaluation of specific cellular immune response against the IE-1 antigen and the CMV pp65, using the technique ELISPOT IFN-γ and individualize the preventive strategy according to the result. In patients with a ELISPOT of "low risk" will be made advance therapy (preemptive therapy) guided by PCR of CMV In patients with a "high risk" ELISPOT, universal prophylaxis with valganciclovir will be performed oral (900 mg / 24h) or intravenous ganciclovir (5-10 mg / Kd / day) in case the oral route is not available. | Diagnostic test | Experimental group |
Primary outcome
Number of patients who have CMV infection in the first year post heart transplant.
Time frame: One year
Any viremia
20 secondary outcomes
Number of patients with late CMV infection.
Time frame: One year
Number of patients with acute rejection.
Time frame: One year
Number of patients with vascular graft disease.
Time frame: One year
Number of patients with other bacterial or viral opportunistic infections.
Time frame: One year
Number of patients with leukopenia secondary to prophylaxis.
Time frame: One year
Number of patients with neutropenia secondary to prophylaxis.
Time frame: One year
Number of leukopenia patients presenting with other bacterial infections or viral.
Time frame: One year
Number of deceased patients during hospital admission post-heart transplant.
Time frame: One year
Number of deceased patients, related to CMV infection, in the first year post-transplant.
Time frame: One year
Number of deceased patients, related to CMV disease, in the first post-transplant year.
Time frame: One year
Number of patients who died from any cause in the first year post-heart transplant.
Time frame: One year
Title of specific Inmunoglobulin G antibodies against serum CMV.
Time frame: One year
Title of nonspecific serum gammaglobulins.
Time frame: One year
CMV-specific memory response B (ELISPOT B).
Time frame: One year
Number of patients whose ELISPOT varies from low to intermediate or high risk.
Time frame: One year
Number of patients whose ELISPOT varies from intermediate or high risk to low risk.
Time frame: One year
Number of spots against the IE-1 antigen.
Time frame: One year
Number of spots against the pp65 antigen.
Time frame: One year
Number of copies of CMV DNA measured by polymerase chain reaction (PCR).
Time frame: One year
Estimate the economic cost of both strategies studied in this clinical trial
Time frame: One year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Dec 2020.
Related trials for Heart Transplant Infection
RecruitingObservational study
CytOSorb TreatMent Of Critically Ill PatientS Registry
Septic Shock, Acute Respiratory Distress Syndrome
RecruitingPhase 3
A Phase 3 Study of Tabelecleucel for Participants With Epstein-Barr Virus-Associated Post-Transplant Lymphoproliferative Disease After Failure With Rituximab or Rituximab and Chemotherapy
Epstein-Barr Virus+ Associated Post-transplant Lymphoproliferative Disease (EBV+ PTLD), Solid Organ Transplant Complications
RecruitingPhase 2/3
Valganciclovir vs. Letermovir for CMV Prophylaxis in Heart Transplant
CMV Viremia, Heart Transplant Infection
RecruitingPhase 4
Safety and Efficacy of Measles, Mumps, Rubella Vaccination in Pediatric Heart Transplantation Patients
Heart Transplant Infection Prevention
Active, not recruitingPhase 2
Open Label Trial of Oral Letermovir for CMV Prophylaxis in Thoracic Transplant Recipients
Cytomegalovirus Infections, Transplant-Related Disorder
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.
Elena García Romero contact
José González Costello principal investigator
Cardiologist
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ELISPOT IFN-γ assay in people with Heart Transplant Infection and CMV Infection, run by Hospital Universitari de Bellvitge at 1 site 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 6 inclusion and 3 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: status not confirmed, as of the sponsor's last update on 23 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Jose González Costello (+0034 932607686, jgonzalez@bellvitgehospital.cat), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients who have CMV infection in the first year post heart transplant. (time frame: One year). 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 23 Dec 2020.