Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients (CYTOPREV)
Cytomegalovirus (CMV) establishes a chronic infection in 60% of the general population. In renal transplant recipients, it is responsible for morbidities occurring mainly in the first 6 months after transplantation. These include viral reactivations linked to immunosuppressive treatment inhibiting the anti-CMV T lymphocyte response. CMV infection, a sign of uncontrolled viral replication, is defined by the detection of viral DNA in the peripheral blood (DNAemia). CMV disease is defined as the association of an infection and symptoms attributable to the virus.
In transplant recipients carrying the virus before transplantation (positive serology: CMV+), two infection prevention strategies are recommended: either close monitoring of DNAemia with antiviral treatment in the event of positive detection (pre-emptive strategy), or antiviral treatment for the first 3 months following the transplant (prophylactic strategy). Both strategies result in the occurrence of CMV infection in 15 to 20% of patients within the first 6 months, with the majority of events occurring between 3 and 6 months.
Numerous studies show that the evaluation of the anti-CMV T lymphocyte response, either before (D0) or early after transplantation (D15), or when antiviral prophylaxis is stopped, allows the identification of patients at risk of CMV infection. No study has yet demonstrated the contribution of such an evaluation in a preventive strategy.
Study Overview
Study Type
Enrollment (Estimated)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Dominique Bertrand
- Phone Number: 0232885452
- Email: dominique.bertrand@chu-rouen.fr
Study Locations
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Rouen, France, 76031
- Recruiting
- CHU Rouen
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Contact:
- Dominique Bertrand, Dr
- Phone Number: 02 32 88 90 02
- Email: Dominique.Bertrand@chu-rouen.fr
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Principal Investigator:
- Dominique Bertrand, Dr
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Renal transplant patient for 1 to 12 days
- CMV seropositivity on the day of transplantation: IgG threshold =6 AU/mL CMIA CMV IgG, Architect i4000 (Abbott)) (Serology performed on D0, before the transplant)
- Non-depleting inducing immunosuppressive treatment (Basiliximab) (implementation before the transplant)
- Affiliation to a social security scheme
- Patient having read and understood the information letter and signed the consent form
Exclusion Criteria:
- Active CMV infection (detectable CMV DNAemia - peripheral CMV DNAemia ≥ 305 IU/mL)
- Patient with hypersensitivity to valganciclovir, ganciclovir, aciclovir or valaciclovir or to any of the excipients
- Lympho-depleting inducing immunosuppressive treatment (antithymoglobulins)
- Neutropenia (neutrophils < 500/mm3) or thrombocytopenia (platelets < 25,000/mm3) or anemia (hemoglobin < 8G/L) identified on routine care samples taken on the day of inclusion
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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Experimental: "Immuno-guided strategy" arm
Participants randomized to the immuno-guided strategy arm will receive a cytomegalovirus (CMV) prevention strategy based on anti-CMV immune response assessment at Day 15 post-transplant.
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"Immuno-guided strategy" arm
|
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Active Comparator: "Universal prophylaxis" arm
Participants randomized to the universal prophylaxis arm will receive antiviral prophylaxis with valganciclovir starting at Day 15 post-transplant and continuing for 3 months following transplantation. Participants will undergo standard clinical and biological monitoring, including CMV DNAemia surveillance, for up to 6 months post-transplant according to routine practice at the participating centers. |
"Immuno-guided strategy" arm
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Demonstrate, in CMV+ transplant patients, the efficacy of an immuno-guided preventive strategy compared to the universal prophylactic strategy, in terms of CMV infection in the 6 months following kidney transplantation.
Time Frame: 6 months
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Proportion of patients with CMV infection within 6 months of transplantation.
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6 months
|
Collaborators and Investigators
Sponsor
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2020/0422/HP
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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