Pre-emptive treatment for cytomegalovirus viraemia to prevent cytomegalovirus disease in solid organ transplant recipients.
Robin Wm Vernooij, Mini Michael, Julia Mt Colombijn...
https://pubmed.ncbi.nlm.nih.gov/39807668Actively Recruiting
Phase 3
Age: 18Years - 75Years
All Genders
ID05708508
Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients
Led by University Hospital, Rouen · Updated on 2026-02-17
144
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Cytomegalovirus (CMV) causes long-lasting infection in about 60% of people and can lead to complications in kidney transplant patients, especially during the first six months after transplantation. This research compares two strategies to prevent CMV infection in patients who test positive for CMV antibodies before their transplant. The study evaluates whether guiding prevention based on the body's immune response can better reduce CMV infection compared to giving antiviral medication to all patients. Participants are randomly assigned to one of two groups. In the immune-guided group, patients have their anti-CMV immune response measured 15 days after transplant. Those at low risk do not receive preventive antiviral drugs but are closely monitored for infection from day 15 to week 28. High-risk patients start antiviral medication at day 15, with treatment adjusted at week 15 based on immune response. The other group follows a universal prophylaxis approach, receiving antiviral medication for three months starting at day 15. Both groups receive regular clinical and laboratory monitoring, including CMV viral load checks for six months. During the study, participants undergo blood tests to detect CMV DNA and immune response assessments. Researchers monitor CMV infection rates up to six months after transplant to compare the two prevention methods. Safety and treatment adherence are also tracked. The entire participation period includes up to six months of follow-up after the kidney transplant to evaluate outcomes and patient health under both strategies.
CONDITIONS
Brief Title
Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients
Who Can Participate
Age: 18Years - 75Years
All Genders
Eligibility Criteria
You may qualify if you...
- Renal transplant patient for 1 to 12 days
- CMV seropositivity on the day of transplantation confirmed by IgG testing
- Received non-depleting immunosuppressive treatment (Basiliximab) before transplant
- Affiliated with a social security scheme
- Patient has read and understood the information letter and signed the consent form
You will not qualify if you...
- Active CMV infection with detectable CMV DNAemia (≥ 305 IU/mL)
- Hypersensitivity to valganciclovir, ganciclovir, aciclovir, valaciclovir, or any excipients
- Received lympho-depleting immunosuppressive treatment (antithymoglobulins)
- Neutropenia (neutrophils < 500/mm3), thrombocytopenia (platelets < 25,000/mm3), or anemia (hemoglobin < 8G/L) on routine care samples at inclusion
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Treatment
Duration - Up to 13 weeks (Day 15 to Week 28 post-transplant)
Participants receive antiviral prophylaxis or are monitored based on immune response assessment starting at Day 15 post-transplant to prevent CMV infection.
Multiple visits for immune response assessments and antiviral treatment monitoring
Follow-up
Duration - Up to 6 months post-transplant
Participants undergo clinical and biological monitoring, including CMV DNAemia surveillance, for up to 6 months post-transplant according to routine practice.
Regular monitoring visits as per routine clinical care
Trial Site Locations
Total: 1 location
1
Chu Rouen
Rouen, France, 76031
Actively Recruiting
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Research Team
D
Dominique Bertrand
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
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