A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China

Lin Zhong

Status

Not yet enrolling

Conditions

Cytomegalovirus (CMV) Infections Among Children and Adult Liver Transplantation Patients in China

Study type

Observational

Funder types

Other

Industry

Identifiers

NCT05958186

SHLTQC-6

Details and patient eligibility

About

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.

Enrollment

800 estimated patients

Sex

All

Volunteers

No Healthy Volunteers

Inclusion criteria

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

Exclusion criteria

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.