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临床试验/NCT03889106
NCT03889106终止不适用

Cardiovascular Function and Ribavirin Pharmacokinetics and Pharmacodynamics in Patients With Lassa Fever

University of Oxford1 个研究点 分布在 1 个国家目标入组 2 人开始时间: 2019年3月1日最近更新:
适应症
干预措施
相关药物

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

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)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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