A Prospective Longitudinal Study of the Effect of Burn Size on Cytomegalovirus Reactivation and Correlates of T Cell Immune Function in Patients Sustaining Significant Burn Injury
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- CMV IgG and viral load PCR
研究概览
简要总结
The purpose of this study is to evaluate the effect of burn injury on the human immune system with a focus on cytomegalovirus (CMV) reactivation and the immunologic correlates of latent viral reactivation.
Subjects will be patients admitted to the North Carolina Jaycee Burn Center with burn injury.
Blood samples will be collected over time and will be evaluated for CMV reactivation and immune cell phenotype.
详细描述
The purpose of this research study is to learn about infections and the immune system in people who suffer from burn injuries. The immune system changes after burn injury and infection is one of the most common complications. Cytomegalovirus (CMV) is a virus that most people are exposed to early in life; once you are exposed it lays inactive in your body forever. When the immune system is suppressed, this virus can reactivate. We would like to measure how this virus makes copies of itself in the blood stream in people with a burn injury and to look at cell markers of the immune system.
This study involves baseline and weekly blood draws for approximately 8 weeks. If blood tests show CMV infection, further monitoring of blood work may be needed after eight weeks.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Burn injury,
- •Positive CMV IgG level confirmative of previous CMV infection and latency.
排除标准
- •Immunocompromising conditions including HIV/AIDS,
- •End-stage renal disease,
- •End-stage liver disease,
- •Pregnancy,
- •Rheumatologic or collagen-vascular disease requiring chronic use of steroids,
- •Chronic use of immunosuppressive agents,
- •Recent chemotherapy, and
- •History of solid organ or allogeneic stem cell transplant.
结局指标
主要结局
CMV IgG and viral load PCR
时间窗: Weekly until viremia resolved (negative viral load by PCR)
次要结局
未报告次要终点
研究者
Bruce Cairns, MD
Medical Director, NC Jaycee Burn Center
University of North Carolina, Chapel Hill