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Covid19NCT04877808

Bacterial Surinfections in COVID-19 ICU Patients

An observational study of Covid19, run by Jessa Hospital at 1 site in Belgium.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Covid19
How many people
116 participants
Where
1 siteBelgium
Study dates
15 Aug 2021to 15 Aug 2021
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

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

Who cannot join

  • None

Trial locations and contacts

1 site in 1 country.

Belgium1 site
  • Jessa hospital

    Hasselt, 3500

Other trials in Belgium

About this study

Official title: Incidence and Predictive Value of Bacterial Surinfections on In-hospital Mortality in COVID-19 ICU Patients: a Longitudinal Single-center Study

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.

Read the detailed description

Approximately 5% of patients with respiratory impairment develop a severe form with acute respiratory failure and require specialized management in the Intensive Care Unit (ICU). Invasive mechanical ventilation (IVM) exposes ICU patients to a particular risk of a nosocomial infectious complication called ventilator-associated pneumonia (VAP). In Europe, the incidence density is 18.3 VAP per 1000 days of IMV.

The coronavirus disease (COVID-19), caused by the severe acute respiratory syndrome coronavirus 2 (SARS CoV-2) emerged in December 2019 and has rapidly spread worldwide (Liu). The mortality of critical ill patients with COVID-19 has been reported variously as low as 11% and as high as 61% (Liu). Since March 2020, several thousand people have been receiving IMV due to severe COVID-19.

Informal exchanges between clinicians regarding the current pandemic indicate a high frequency of VAP. Several factors may account for a higher incidence of VAP in the population hospitalized in the ICU for SARS CoV-2 infection (Blonz 2021):

  • A longer ventilation period, leading to greater mechanical exposure to the risk of VAP.
  • The frequency of comorbidities.
  • The frequency of ARDS, which is associated with a higher incidence of VAP.
  • A form of acquired immunosuppression related to SARS-CoV-2 infection,
  • Organizational factors related to the fact that this is the first major pandemic in modern history

Aim 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.

Design This is a retrospective, single-center study investigating the incidence of bacterial surinfections in COVID-19 patients admitted to the ICU from 13th of March 2020 until 17th of October 2020.

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

Outcome measures The primary endpoint of this retrospective 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 17th of October 2020.

Secondary endpoints are 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 as well as the associations between the presences of thrombi and bacteremia/catheter sepsis in COVID-19 patients admitted to the ICU between 13th of March 2020 until 17th of October 2020.

Additional data collection

Additional collected parameters are listed below and are collected as a standard-of-care in our hospital:

  • Demographics: i.e age, gender, BMI
  • DNR code
  • Comorbidities: smoking, obesity, hypertension, diabetes, cardiovascular disease, respiratory disease, malignancies, renal failure (AKI), liver failure, gastrointestinal disease, neurological conditions, mental state, other
  • Symptoms at the time of admission to ICU: i.e fever, body temperature, dyspnoea, headache, diarrhea etc…
  • Laboratory results of all standard parameters measured
  • Treatment: antiviral agents, antibiotics, corticosteroids, etc…
  • Complications: shock, heart failure, sepsis, stroke, bacteraemia, VAP, type of bacteria causing the infection, … etc
  • Ventilation: method, PEEP, FiO2, P/F ratio ..
  • Radiological findings: pneumonia, ground-glass opacity..
Conditions
Covid19
Medical subject headings
COVID-19

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of sepsis

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

    Measured: through study completion, 8 months

  2. Incidence of VAP

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

    Measured: through study completion, 8 months

  3. Incidence of bacterial catheter infections

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

    Measured: through study completion, 8 months

Secondary outcomes (7)
  1. Correlation with corticosteroids

    Correlation of bacterial surinfections with the dose of cortisosteroids

    Measured: through study completion, 8 months

  2. Correlation with the length of stay in ICU and hospital

    Correlation of bacterial surinfections with the length of stay in ICU and hospital

    Measured: through study completion, 8 months

  3. Correlation with venous thromboembolism

    Correlation of bacterial surinfections with the presence of venous thromboembolism

    Measured: through study completion, 8 months

  4. Correlation with the number of bacterial episodes

    Correlation of bacterial surinfections with the number of bacterial episodes

    Measured: through study completion, 8 months

  5. Correlation with the types

    Correlation with the different types of bacteria

    Measured: through study completion, 8 months

  6. Correlation with ICU mortality

    Correlation of bacterial surinfections with the ICU mortality

    Measured: through study completion, 8 months

  7. Correlation between presences of thrombi and bacteremia/catheter sepsis

    Correlation between presences of thrombi and bacteremia/catheter sepsis

    Measured: through study completion, 8 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2021
  2. Study start15 Aug 2021
  3. Primary completion15 Aug 2021
  4. Study completion15 Aug 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Retrospective
Enrolment
116 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04877808
Sponsor's protocol ID
f2021/037
Status last verified
Aug 2021
First submitted
3 May 2021
Last updated
30 Aug 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: None sharing

Questions about this trial

What is this clinical trial studying?

An observational study of Covid19, run by Jessa Hospital at 1 site in Belgium.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of sepsis (time frame: through study completion, 8 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.

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