跳至主要内容
临床试验/NCT02431923
NCT02431923已完成不适用

Partnership for Research on Ebola Virus (PREVAIL) Prevail III: Ebola Natural History Study

National Institute of Allergy and Infectious Diseases (NIAID)4 个研究点 分布在 2 个国家目标入组 4,043 人开始时间: 2017年12月2日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
4,043
试验地点
4
主要终点
To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients.

研究概览

简要总结

Background:

  • Ebola is a lethal disease. A lot is still unknown about Ebola and its long-term effects. Researchers want to learn what ill health conditions Ebola survivors have. They want to learn if Ebola survivors can infect others in their household through close contact. They also want to learn if Ebola survivors are immune from getting Ebola again. To learn these things, they want to follow people in Liberia for 5 years.

Objectives:

  • To learn how Ebola affects the health of survivors and the people they live with.

Eligibility:

  • People in Liberia who had Ebola in the past 2 years, who share a household with someone who had Ebola, or who got ill and went to an Ebola Treatment Unit but were sent home because they did not have Ebola.

Design:

  • Participants will be screened with family illness history, physical exam, and blood tests. They may have an eye exam.
  • Ebola survivors and those who went to a Treatment Unit but did not have Ebola will visit a clinic at 3, 6, and 12 months, then every 6 months for 5 years. At each visit, they will repeat the screening tests.
  • Participants who live with someone who had Ebola will have only the screening visit. But they may be asked to return for follow-up visits. These visits will help researchers learn more about the differences between those who have had Ebola and those who have not.
  • Participants brought to the NIH Clinical Center will have documentation of positive Ebola virus PCR and a clinical syndrome compatible with acute EVD.
  • The study will last 5 years.

详细描述

Between 1994 and the present, there have been several Ebola virus outbreaks affecting mostly countries in Central Africa. However, the 2014 West African outbreak significantly exceeds all previous outbreaks in geographic range and number of individuals affected. Ebola virus disease (EVD) is highly lethal with case fatality rates of 70-80% in the current West African outbreak. While the clinical manifestations of acute Ebola virus infection are well documented, little is known about long-term sequelae, ability to transmit Ebola, or long-term protective immunity in survivors from EVD. The purpose of this protocol is to study these questions in a cohort of EVD survivors from Liberia.

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
— 至 100 Years(Child, Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

To characterize the clinical sequelae seen in convalescent Ebola virus disease (EVD) patients.

时间窗: Throughout

longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD

Assess whether convalescent EVD patients can transmit infection to household and sexual contacts as determined by development of EVD or Ebola seroconversion in contacts

时间窗: Throughout

longterm sequelae, ability to transmit Ebola, or long-term protective immunity in survivors convalescing from EVD

次要结局

  • Better define the immune response in EVD survivors.(Throughout)

研究者

申办方类型
Nih
责任方
Sponsor

研究点 (4)

Loading locations...

相似试验

Ebola Virus Disease Survivors: Clinical and... | 临床试验