A Study of Cytomegalovirus Disease Epidemiology in Pediatric and Adult Liver Transplant Recipients in China
Study Details
Study Description
Brief Summary
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:
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The incidence of Cytomegalovirus (CMV) Infections (including clinical significant CMV reactivations and CMV Diseases) among children and adults Liver transplantation patients in China
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All-cause Mortality (Survival probability at 1 year)
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Incidence of Allograft Rejection. Number of subjects with allograft rejection
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Graft Loss. Incidence of graft loss (re-transplantation)
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Late-onset CMV Disease. Incidence of late-onset CMV disease (occurring after 100 days post-randomization) as adjudicated by end point committee
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Bacterial Infections. Incidence of bacterial opportunistic infections
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Major Fungal Infections. Opportunistic fungal infections
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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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
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Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Children group Ages≤18 |
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| Adults group Ages>18 |
Outcome Measures
Primary Outcome Measures
- Clinically significant CMV reactivation or CMV disease was observed within 12 months of transplantation [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.
- End of follow-up survey [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.
- Death [Within 22 months after liver transplantation]
The participant died
Secondary Outcome Measures
- Loss to follow-up survey [Within 22 months after liver transplantation]
During follow-up, if we can not connect with participant, we regard this event as loss to follow-up.
- Participants asked to withdraw [Within 22 months after liver transplantation]
During follow-up, participants refuse to keep this study within 22 months after liver transplantation
Eligibility Criteria
Criteria
Inclusion Criteria:
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Have received their first orthotopic liver transplant (the transplanted liver may be deceased donor or live donor graft) within 10 days prior.
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Children group: Age ≤18yeas；
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Adults group: Age >18yeas；
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Willingness to participate in the study
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Ability to understand information material
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Written informed consent
Exclusion Criteria:
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Have known Human immunodeficiency virus (HIV) infection (based on testing performed during the transplant evaluation process).
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Participation in another investigational agent trial
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Be undergoing multi organ transplant or have undergone prior organ transplant. Have expected life expectancy of less than 72 hours.
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Lin Zhong
- Merck Sharp & Dohme LLC
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- SHLTQC-6