Risks of Bacterial and Fungal Superinfection in Patients With COVID-19

Study Overview
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Brief Summary
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Infection with bacteria or fungi can be deadly. Often, these types of infections can lead to an increase in the severity of illness requiring intensive care unit (ICU) admission, prolonged duration of treatment and further risks associated with additional infections and superinfections. These are also called hospital acquired secondary infections. Patients who contract COVID-19 and require an ICU admission are at increased risk of contracting these secondary infections, and receive certain medications that can lower your body's immune response. In COVID-19 patients who require these treatments, it is unclear what affect these medications can have on developing an additional infection as well as the rate of recovery/survival. This study is evaluating the effect these medications have on the development of secondary infections and rate of survival of COVID-19 patients that have been admitted to ICUs.

Official Title
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Risks of Bacterial and Fungal Superinfection in Patients With COVID-19 Stratified by New and Pre-existing Immunosuppression: a Retrospective, Observational, Multisite, Multinational Cohort Study

Conditions
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COVID-19

Intervention / Treatment
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* Other: Previously admitted COVID-19 patients in intensive care units


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hospital admission date from 1 July 2020 to 30 June 2021 Positive test for COVID-19 collected within 1 week of admission date ICU admission within 60 days after hospital admission date Exclusion Criteria: Hospital admission shorter than 5 days Persons younger than 18 years of age

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Previously admitted COVID-19 patients in intensive care units<br>Infectious Diseases Physicians from participating hospitals will identify patients with COVID-19 admitted to their hospital who had an intensive care unit stay during the first 60 days after hospital admission. | Other: Previously admitted COVID-19 patients in intensive care units<br>* Exposure: this is a retrospective, observational study that does not include an intervention. Data collected for this study will be from previously hospitalized COVID-19 patients who had an intensive care unit stay during their admission<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Describe the incidence, management and outcomes of secondary infections in COVID-19 patients admitted to intensive care units | Data collected from medical records of patients will include demographics, medical history, details of bacterial and fungal infections in the first 60 days after admission (includes aetiological pathogen, sample isolated from and antimicrobial susceptibility), treatment received for COVID-19 with antiviral or immunomodulatory therapy and disposition at 60 days from hospital admission | Within the first 60 days of hospital admission | 
| Compare clinical and microbiological outcomes based on treatment appropriateness in COVID-19 patients admitted to intensive care units | Data collected from medical records of patients will include demographics, medical history, details of bacterial and fungal infections in the first 60 days after admission (includes aetiological pathogen, sample isolated from and antimicrobial susceptibility), treatment received for COVID-19 with antiviral or immunomodulatory therapy and disposition at 60 days from hospital admission | Within the first 60 days of hospital admission | 
| Assess the use and effect of immune suppression in COVID-19 patients admitted to intensive care units. | Data collected from medical records of patients will include demographics, medical history, details of bacterial and fungal infections in the first 60 days after admission (includes aetiological pathogen, sample isolated from and antimicrobial susceptibility), treatment received for COVID-19 with antiviral or immunomodulatory therapy and disposition at 60 days from hospital admission | Within the first 60 days of hospital admission | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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secondary infections, bacterial infections, fungal infections