NCT04877808

Brief Summary

The aim of this study is to assess the incidence of bacterial surinfections (sepsis, VAP and catheter infections) in COVID-19 patients admitted to the ICU from 13th of March 2020 until 17h of October 2020. In addition, the association of these infections with the dose of corticosteroids, the length of stay in ICU and in hospital, the presence of venous thromboembolism, the number of bacterial episodes, the different types of bacteria causing the infections and ICU mortality will be evaluated as well as the associations between the presences of thrombi and bacteremia/catheter sepsis.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
116

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Aug 2021

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

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 3, 2021

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 7, 2021

Completed
3 months until next milestone

Study Start

First participant enrolled

August 15, 2021

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 15, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 15, 2021

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

Same day

First QC Date

May 3, 2021

Last Update Submit

August 27, 2021

Conditions

Outcome Measures

Primary Outcomes (3)

  • Incidence of sepsis

    Incidence of bacterial surinfections (sepsis) in COVID-19 patients admitted to the ICU

    through study completion, 8 months

  • Incidence of VAP

    Incidence of bacterial surinfections (VAP) in COVID-19 patients admitted to the ICU

    through study completion, 8 months

  • Incidence of bacterial catheter infections

    Incidence of bacterial surinfections (catheter infections) in COVID-19 patients admitted to the ICU

    through study completion, 8 months

Secondary Outcomes (7)

  • Correlation with corticosteroids

    through study completion, 8 months

  • Correlation with the length of stay in ICU and hospital

    through study completion, 8 months

  • Correlation with venous thromboembolism

    through study completion, 8 months

  • Correlation with the number of bacterial episodes

    through study completion, 8 months

  • Correlation with the types

    through study completion, 8 months

  • +2 more secondary outcomes

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

All adult COVID-19 patients admitted to the ICU from 13th of March until 17th of October 2020 were included.

You may qualify if:

  • All adult COVID-19 patients admitted to the ICU from 13th of March until 17th of October 2020 were included.

You may not qualify if:

  • None

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jessa hospital

Hasselt, 3500, Belgium

Location

MeSH Terms

Conditions

COVID-19

Condition Hierarchy (Ancestors)

Pneumonia, ViralPneumoniaRespiratory Tract InfectionsInfectionsVirus DiseasesCoronavirus InfectionsCoronaviridae InfectionsNidovirales InfectionsRNA Virus InfectionsLung DiseasesRespiratory Tract Diseases

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

May 3, 2021

First Posted

May 7, 2021

Study Start

August 15, 2021

Primary Completion

August 15, 2021

Study Completion

August 15, 2021

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

None sharing

Locations