NCT04815174

Brief Summary

This study highlighted the possibility, even in epidemic settings, of providing advanced supportive care for patients with VMEs. Indeed, while the prospect of offering any invasive medical care was widely discussed in 2014 in West Africa with the aim of limiting the exposure of caregivers, the epidemic of 2018-2019 has on the contrary seen the development of a number of medical care strategies, in parallel with the deployment of specific treatments. This study aims to describe a cohort of patients receiving this upgraded supportive care during the tenth epidemic in the DRC.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
711

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2018

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2019

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

March 17, 2021

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

1.4 years

First QC Date

March 17, 2021

Last Update Submit

March 23, 2021

Conditions

Outcome Measures

Primary Outcomes (1)

  • Mortality

    Any type mortality during hospitalization

    Through the end of the hospitalization, with an average of 11 days

Interventions

(i) advanced clinical and biological monitoring system (ii) symptomatic treatment adapted to the patient's needs, such as antibiotic therapy, oxygen therapy and blood transfusion; (iii) dialysis or mechanical ventilation.

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

All patients with positive RT-PCR admitted in ETC's during the inclusion period were included in the study

You may qualify if:

  • Laboratory confirmed Ebola Virus Disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

BENI ETC

Beni, North Kivu, Democratic Republic of the Congo

Location

MeSH Terms

Conditions

Hemorrhagic Fever, Ebola

Interventions

Standard of Care

Condition Hierarchy (Ancestors)

Hemorrhagic Fevers, ViralRNA Virus InfectionsVirus DiseasesInfectionsFiloviridae InfectionsMononegavirales Infections

Intervention Hierarchy (Ancestors)

Quality Indicators, Health CareQuality of Health CareHealth Services AdministrationHealth Care Quality, Access, and Evaluation

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 17, 2021

First Posted

March 24, 2021

Study Start

August 1, 2018

Primary Completion

December 31, 2019

Study Completion

December 31, 2019

Last Updated

March 24, 2021

Record last verified: 2021-03

Locations