Covid19NCT04877808
Bacterial Surinfections in COVID-19 ICU Patients
An observational study of Covid19, run by Jessa Hospital at 1 site in Belgium.
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.
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.
Incidence of sepsis
Incidence of bacterial surinfections (sepsis) in COVID-19 patients admitted to the ICU
Measured: through study completion, 8 months
Incidence of VAP
Incidence of bacterial surinfections (VAP) in COVID-19 patients admitted to the ICU
Measured: through study completion, 8 months
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)
Correlation with corticosteroids
Correlation of bacterial surinfections with the dose of cortisosteroids
Measured: through study completion, 8 months
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
Correlation with venous thromboembolism
Correlation of bacterial surinfections with the presence of venous thromboembolism
Measured: through study completion, 8 months
Correlation with the number of bacterial episodes
Correlation of bacterial surinfections with the number of bacterial episodes
Measured: through study completion, 8 months
Correlation with the types
Correlation with the different types of bacteria
Measured: through study completion, 8 months
Correlation with ICU mortality
Correlation of bacterial surinfections with the ICU mortality
Measured: through study completion, 8 months
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.
- First posted7 May 2021
- Study start15 Aug 2021
- Primary completion15 Aug 2021
- Study completion15 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Covid19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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)
Sponsor and investigators
- Lead sponsor
- Jessa Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Stessel Björn, Jessa Hospital
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
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Incidence and Predictive Value of Bacterial Surinfections on In-hospital Mortality in COVID-19 ICU Patients: a Longitudinal Single-center Study
- ClinicalTrials.gov ID
- NCT04877808
- Acronym / sponsor ID
- f2021/037
- Conditions
- Covid19
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 116 participants (actual)
- Lead sponsor
- Jessa HospitalUniversity, hospital or other
- Study start
- 15 Aug 2021 (actual)
- Primary completion
- 15 Aug 2021 (actual)
- Study completion
- 15 Aug 2021 (actual)
- First posted
- 7 May 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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..
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- 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.
Key inclusion criteria (1 listed)
- All adult COVID-19 patients admitted to the ICU from 13th of March until 17th of October 2020 were included.
Key exclusion criteria (1 listed)
- None
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Incidence of sepsis
Time frame: through study completion, 8 months
Incidence of bacterial surinfections (sepsis) in COVID-19 patients admitted to the ICU
Incidence of VAP
Time frame: through study completion, 8 months
Incidence of bacterial surinfections (VAP) in COVID-19 patients admitted to the ICU
Incidence of bacterial catheter infections
Time frame: through study completion, 8 months
Incidence of bacterial surinfections (catheter infections) in COVID-19 patients admitted to the ICU
7 secondary outcomes
Correlation with corticosteroids
Time frame: through study completion, 8 months
Correlation with the length of stay in ICU and hospital
Time frame: through study completion, 8 months
Correlation with venous thromboembolism
Time frame: through study completion, 8 months
Correlation with the number of bacterial episodes
Time frame: through study completion, 8 months
Correlation with the types
Time frame: through study completion, 8 months
Correlation with ICU mortality
Time frame: through study completion, 8 months
Correlation between presences of thrombi and bacteremia/catheter sepsis
Time frame: through study completion, 8 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Individual participant dataSharing planned: No. None sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
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.