A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 800
- 试验地点
- 1
- 主要终点
- End of follow-up survey
研究概览
简要总结
The goal of this observational study is to learn about cytomegalovirus disease epidemiology in pediatric and adult liver transplant recipients in China. The main questions it aims to answer are:
- The incidence of Cytomegalovirus (CMV) Infections (including clinical significant CMV reactivations and CMV Diseases) among children and adults Liver transplantation patients in China
- All-cause Mortality (Survival probability at 1 year)
- Incidence of Allograft Rejection. Number of subjects with allograft rejection
- Graft Loss. Incidence of graft loss (re-transplantation)
- Late-onset CMV Disease. Incidence of late-onset CMV disease (occurring after 100 days post-randomization) as adjudicated by end point committee
- Bacterial Infections. Incidence of bacterial opportunistic infections
- Major Fungal Infections. Opportunistic fungal infections
- Major Non-CMV Viral Infections. Incidence of non-CMV viral infections We will collect demographic data of participants. All recipients and donors underwent preoperative testing for CMV pp65 antigenemia, plasma CMV DNA, and serum CMV antibody. All the recipients were followed up in a liver transplant follow-up clinic twice weekly for a month after discharge from hospital. After that, patients were followed up weekly for 3 months, fortnightly for 6 months, and monthly for 12 months.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior.
- •Children group: Age ≤18yeas；
- •Adults group: Age >18yeas；
- •Willingness to participate in the study
- •Ability to understand information material
- •Written informed consent
排除标准
- •Have known Human immunodeficiency virus (HIV) infection (based on testing performed during the transplant evaluation process).
- •Participation in another investigational agent trial
- •Be undergoing multi organ transplant or have undergone prior organ transplant. Have expected life expectancy of less than 72 hours.
研究组 & 干预措施
Prophylaxis Strategy Cohort
Consecutive patients receiving universal antiviral prophylaxis as the standard-of- care CMV prevention strategy post-transplant.
Preemptive Strategy Cohort
Consecutive patients managed with a preemptive therapy strategy (monitoring and treatment upon viremia) post-transplant.
No Prevention Strategy Cohort
Consecutive patients who did not receive systematic universal prophylaxis or preemptive therapy for CMV post-transplant.
结局指标
主要结局
End of follow-up survey
时间窗: Within 22 months after liver transplantation
We will perform a follow-up for 22 months if participant is alive and does not observed CMV reactivation.
Clinically significant CMV reactivation or CMV disease was observed within 12 months of transplantation
时间窗: Within 22 months after liver transplantation
1. CMV reactivation: CMV-lgG is positive and any one of CMV-lgM, pp65 and CMV-DNA is positive is called CMV reactivation.
Death
时间窗: Within 22 months after liver transplantation
The participant died
Number of Participants With Clinically Significant CMV Reactivation or CMV Disease
时间窗: Within 12 months after liver transplantation
Clinically significant CMV reactivation was defined as a positive CMV-DNA PCR or pp65 antigenemia test in the context of clinical symptoms attributable to CMV. CMV disease was defined as evidence of CMV infection with documented end-organ disease (e.g., CMV hepatitis, colitis, pneumonitis) according to established international guidelines.
Number of Participants Who Completed the 12-Month Follow-up
时间窗: Within 12 months after liver transplantation
Participants were considered to have completed the study if they were alive and did not experience CMV reactivation requiring study closure, and provided data through the 12-month post-transplant visit.
All-Cause Mortality
时间窗: Within 12 months after liver transplantation
The occurrence of death from any cause within 12 months post-transplantation. As this was an observational study, mortality was assessed as an efficacy outcome (to calculate survival probability) rather than a solicited adverse event. Deaths were identified through scheduled study follow-ups, review of medical records, and when necessary, verification with civil registries.
次要结局
- Loss to follow-up survey(Within 22 months after liver transplantation)
- Participants asked to withdraw(Within 22 months after liver transplantation)
- Number of Participants Lost to Follow-up(Within 12 months after liver transplantation)
- Participants Asked to Withdraw(Within 12 months after liver transplantation)
研究者
Lin Zhong
Professor
Shanghai General Hospital, Shanghai Jiao Tong University School of Medicine