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Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients

Study acronym: CYTOPREV
StatusRecruiting
PhasePhase 3
Started2024-03-28
View on ClinicalTrials.gov ↗

Amendment history

2026-02-13
notable
Not Yet Recruiting→Recruiting Study Status, Study Description, Arms and Interventions, Contacts/Locations v1
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2026-12-31→2027-04
Completion date2027-06-01→2027-04
Start dateestimated 2023-08-31→confirmed 2024-03-28
Study sites0→1
2023-01-23
minor
Original filing
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.
Trial Details
NCT Number NCT05708508
Lead Sponsor University Hospital, Rouen
Conditions Kidney Transplant Infection
Enrollment 144 participants
Start Date 2024-03-28
Primary Completion 2027-04 (estimated)
Study Completion 2027-04 (estimated)
Updated on ClinicalTrials.gov 2026-02-17