Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 2
- 试验地点
- 1
- 主要终点
- Ribavirin PK - primary
研究概览
简要总结
Lassa fever carries a treated mortality in hospitalized patients of up to 50%. Lassa fever is often described as being characterized by vascular leak and shock in the terminal phase, but, whilst animal data supports this, there are limited data in humans. Therefore, an aim of this study therefore is to characterize cardiovascular function in patients with Lassa fever, with the ultimate goal of informing future trials of supportive or therapeutic strategies.
Ribavirin is the current standard of care. However, the efficacy of ribavirin has not been established in a randomised controlled trial (RCT). There is very limited pharmacokinetic (PK) data on ribavirin in patients with Lassa fever and the optimal dose of ribavirin for an RCT is unknown. Furthermore, there are various hypothesized mechanisms of action of ribavirin, none of which have been investigated in humans with Lassa fever. Further aims of this study therefore are to characterize the PK of ribavirin in Lassa fever, and identify any associations between ribavirin PK parameters, viral load and markers of immune/inflammatory status.
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
- 10 Years 至 —(Child, Adult, Older Adult)
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Positive antigen or PCR test for Lassa fever
- •Aged 10 years or above
排除标准
- •Patients for end of life care only
研究组 & 干预措施
Lassa fever
干预措施: Ribavirin (Drug)
结局指标
主要结局
Ribavirin PK - primary
时间窗: Up to 15 days during hospitalisation
Proportion of patients with ribavirin CMIN above the IC90 at all measured CMIN during therapy
Ribavirin PD (mechanism of action) - primary
时间窗: Up to 15 days during hospitalisation
• Change in Lassa virus viral load (copies/ml) from baseline to day 3/5
Cardiovascular function - primary
时间窗: Up to 28 days during hospitalisation
Death during hospitalization
次要结局
- Cardiovascular function - secondary(Up to 28 days during hospitalisation)
- Ribavirin PK - secondary(Up to 15 days during hospitalisation)
- Ribavirin PD (mechanism of action)(Up to 15 days during hospitalisation)
