Effectiveness of an Immune-guided Cytomegalovirus Infection Preventive Strategy Compared to a Universal Prophylactic Strategy in Renal Transplant Patients
概览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- University Hospital, Rouen
- 入组人数
- 144
- 试验地点
- 1
- 主要终点
- 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.
概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
"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.
- Participants classified as low risk will not receive systematic antiviral prophylaxis and will undergo preemptive monitoring for CMV infection from Day 15 to Week 28 post-transplant.
- Participants classified as high risk (anti-CMV immune response <130 SFC/10⁶ cells) will receive antiviral prophylaxis with valganciclovir starting at Day 15 post-transplant. At Week 15, antiviral treatment will be discontinued in participants reclassified as low risk. Participants remaining classified as high risk will continue antiviral treatment until Week 28 post-transplant.
干预措施: ROVALCYTE (Drug)
"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.
干预措施: ROVALCYTE (Drug)
结局指标
主要结局
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.
时间窗: 6 months
Proportion of patients with CMV infection within 6 months of transplantation.
次要结局
未报告次要终点