Prophylactic Therapy for Cytomegalovirus in Liver Transplant Recipients: A Single Center Experience With Oral Ganciclovir Versus Valganciclovir
试验速览
- 阶段
- 不适用
- 入组人数
- 200
研究概览
简要总结
Null Hypothesis:
There is no significant difference in the incidence of CMV infection when using oral valganciclovir or ganciclovir as prophylactic anti-viral therapy.
Alternate Hypothesis:
There exists a significant difference in the incidence of CMV infection when oral valganciclovir is used for CMV prophylaxis rather than oral ganciclovir. A formal hypothesis to be tested should be defined.
详细描述
The objective for this retrospective clinical study is to describe the incidence of CMV infection in orthoptic liver transplant recipients who receive oral valganciclovir or ganciclovir as their CMV prophylactic anti-viral therapy.
Endpoints:
Primary Endpoint
CMV infection will be characterized as viremia, syndrome or disease by the abovementioned methods for up to one year post-transplantation.
Secondary Endpoints
研究设计
- 研究类型
- Observational
- 观察模型
- Defined Population
- 时间视角
- Other
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All liver transplants will be performed at Oregon Health & Science University (OHSU) and the OHSU surgical and medical staff will treat patients.
排除标准
- •Portland Veterans Affairs Medical Center liver transplant recipients
- •Patients deceased within thirty days of receiving liver allograft
- •Patients with low risk of acquiring CMV infection: donor-negative and recipient-negative (D-/R-)
- •Patients undergoing re-transplantation
- •Lost to follow-up (minimum follow-up is 1 year)
- •History of CMV infection or disease
- •Anti-CMV therapy within the past 30 d
- •Severe, uncontrolled diarrhea or evidence of malabsorption.