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Study of Filovirus Disease Morbi-mortality (TEMBO)

2026年9月9日 更新者:Assistance Publique - Hôpitaux de Paris

Prospective Observational Study of the Mortality of Patients With Filovirus Disease

Filoviruses, including Ebola and Marburg, cause hemorrhagic fevers associated with high mortality and still limited scientific literature, in particular for some rare species such as the Bundibugyo virus. The current epidemic of Bundibugyo virus disease in the Democratic Republic of the Congo (DRC) and Uganda, which has been declared a public health emergency of international concern by the World Health Organization (WHO), illustrates the importance of better characterizing this infection, whose genetic specificities complicate the transposition of diagnostic, therapeutic and vaccine tools developed for Ebola Zaire.

Given the incubation time of filoviruses and international mobility, cases can be diagnosed and managed outside of epidemic areas, including in exposed caregivers. However, clinical, biological and therapeutic knowledge available in this context remain very limited.

This situation justifies the implementation of an observational cohort of patients with a confirmed filovirus disease, who have arrived or were diagnosed in France.

This cohort will describe the clinical evolution of the disease, its prognosis and its pathophysiology, as well as identify new diagnostic, therapeutic or preventive leads.

研究概览

地位

尚未招聘

详细说明

Filoviruses, including Ebola Zaire, Sudan, Bundibugyo, Tai Forest and Marburg virus, are responsible for haemorrhagic fevers with high overall mortality: a recent meta-analysis reports an average case fatality rate of 59%, with extremes of 20 to 90% depending on the epidemic. Between 1976 and 2014, about twenty epidemics of filoviruses diseases (FVD) occurred in Central Africa, without much scientific documentation. The largest ever is an outbreak of Ebola virus disease (EVD) declared in West Africa between 2014 and 2016 (in Guinea, Liberia, and Sierra Leone) and recorded 11,310 deaths for 28,616 cases. Currently, an outbreak of Bundibugyo virus disease (BVD) is active in the Democratic Republic of Congo (DRC) (Ituri and North Kivu provinces) and Uganda.

It was declared a "public health emergency of international concern" by the World Health Organization (WHO) on May 17, 2026. It currently has 399 deaths out of 1333 cases reported as of June 29, 2026, reflecting the scale of the outbreak. Bundibugyo virus (BDBV) was first identified in 2007 in Uganda. The epidemic is only the third documented emergence of BVD, following those observed in Uganda in 2007 and in the DRC in 2012. The lethality of BVD is estimated to be approximately 25%. Genetically, BDBV is different from the most common species, the Zaire Ebola virus (EBOV), in a proportion of about 40%. This genetic distance explains the difficulties in adapting diagnostic approaches (molecular biology) and therapeutic approaches (monoclonal antibodies, direct-acting antivirals, and vaccines) developed for EBOV.

By the incubation period, in the order of 2 to 21 days, and the ease of air travel in the 21st century, we can expect that cases of FVD are diagnosed and treated outside of epidemic areas (in particular the healthcare staff working in epidemic areas and contaminated in a nosocomial way). During previous filovirus epidemics, a very small number of infected people were treated outside the epidemic areas. Therefore, little is known to date about the clinical and biological characteristics and the treatment history of filovirus diseases in patients managed outside the African context.

In this context, it is necessary to set up an observational cohort study of any case of disease with proven filovirus that arrived or was diagnosed in the national territory in order to describe the disease, its clinical course, prognosis, as well as to study its pathophysiology to identify new targets for the diagnosis and curative and preventive treatment.

Knowledge on filovirus diseases acquired during the care of patients with EVD outside of epidemic areas are very fragmented and the absence of biological collections taken from the few patients with EVD in previous epidemics and hospitalized in Europe or the United States did not allow us to describe interactions between the host and the pathogenic species, this being particularly true for rare strains such as the BDBV. Given the genetic distance between species, and that this is the largest epidemic to date caused by the Bundibugyo species, BVD may have clinical, biological, and prognostic features different from other filoviruses.

研究类型

观察性的

注册 (估计的)

10

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习联系方式

研究联系人备份

学习地点

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

  • 孩子
  • 成人
  • 年长者

接受健康志愿者

不

取样方法

非概率样本

研究人群

Any individual, including adults, children, minors under 18, and pregnant women, with a filovirus infection:

  • Either repatriated to the national territory with a virologically confirmed diagnosis
  • Or virologically diagnosed within the national territory

描述

Inclusion criteria :

  • Confirmed filovirus disease
  • Hospitalized in a Referenced Healthcare Facility in France

Non inclusion criteria :

  • Refusal by the patient or their legal representative to sign the consent form for the study
  • Patient deprived of their liberty or subject to a legal protection measure

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

队列和干预

团体/队列
Patients with a confirmed filovirus disease

Any individual, adult or minor, including pregnant women, suffering from a filovirus disease and responding to one of the following situations:

  • person repatriated to the national territory with a confirmed virological diagnosis
  • person who has received a virologically confirmed diagnosis in France

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Vital status on day 28.
大体时间:28 days

The objective is to describe mortality at day 28 in patients with confirmed filovirus diseases.

Day 1 is the day of the first documented positive PCR, regardless of the location of the PCR.

28 days

次要结果测量

结果测量
措施说明
大体时间
Symptoms collected daily until discharge from hospitalization
大体时间:12 months
The aim is to describe the natural history of the disease
12 months
All-cause mortality at day 90
大体时间:90 days
The objective is to describe mortality on day 90
90 days
Failure of at least one organ requiring intensive care between D1 and D90 or death
大体时间:90 days
The objective is to identify the factors associated with a severe form of the disease (failure of at least one organ requiring management in intensive care) and death.
90 days
Dosage of supportive care received up to day 28 or hospital discharge
大体时间:28 days
The objective is to describe the supportive care received by patients as part of the care
28 days
Duration of supportive care administered through Day 28 or hospital discharge
大体时间:28 days
The objective is to describe the supportive care received by patients as part of the care
28 days
Drug administered through Day 28 or hospital discharge
大体时间:28 days
The objective is to describe the supportive care received by patients as part of the care
28 days
Vital status on day 28 by subgroups: patients who have received or have not received antiviral and/or immunomodulatory tests
大体时间:28 days
The objective is to describe the response in terms of mortality according to the specific treatments received (antiviral and/or immunomodulator).
28 days
Quantitative viral load at each assessment time point : blood, urine, saliva, vaginal fluid, semen
大体时间:12 months
The objective is to study the viral kinetics in blood and other biological samples
12 months
Assessment of innate and adaptive immune responses at each available time point, including M6 and M12.
大体时间:12 months
The objective is to characterize host responses to understand its pathogenesis, including innate immune responses and acquired, circulating levels of immune signaling molecules in peripheral blood to identify new diagnostic and prognostic biomarkers as well as potential therapeutic avenues.
12 months
Assessment of circulating levels of immune signaling molecules in peripheral blood, at each available time point, particularly at M6 and M12.
大体时间:12 months
The objective is to characterize host responses to understand its pathogenesis, including innate immune responses and acquired, circulating levels of immune signaling molecules in peripheral blood to identify new diagnostic and prognostic biomarkers as well as potential therapeutic avenues.
12 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (估计的)

2026年9月1日

初级完成 (估计的)

2031年9月1日

研究完成 (估计的)

2032年9月1日

研究注册日期

首次提交

2026年8月28日

首先提交符合 QC 标准的

2026年9月9日

首次发布 (实际的)

2026年9月16日

研究记录更新

最后更新发布 (实际的)

2026年9月16日

上次提交的符合 QC 标准的更新

2026年9月9日

最后验证

2026年8月1日

更多信息

与本研究相关的术语

其他研究编号

  • APHP260973
  • 2026-A01690-51 (其他标识符:ANSM)

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

不

研究美国 FDA 监管的设备产品

不

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