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

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.

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Key information

Conditions

COVID-19 Bacterial Infections Bacterial Infections and Mycoses Coinfection Coronaviridae Infections Coronavirus Infections Infections Lung Diseases Mycoses Nidovirales Infections Pneumonia Pneumonia, Viral RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Royal Brisbane and Women's Hospital, Herston, Queensland, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Previously admitted COVID-19 patients in intensive care units

Other

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

Primary outcomes

Describe the incidence, management and outcomes of secondary infections in COVID-19 patients admitted to intensive care units

Time frame: Within the first 60 days of hospital admission

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
Compare clinical and microbiological outcomes based on treatment appropriateness in COVID-19 patients admitted to intensive care units

Time frame: Within the first 60 days of hospital admission

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
Assess the use and effect of immune suppression in COVID-19 patients admitted to intensive care units.

Time frame: Within the first 60 days of hospital admission

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

Sponsors and collaborators

Lead sponsor

The University of Queensland

Other

Collaborators

Christian Medical College, Vellore, India
Merck Sharp & Dhome (Australia) Pty. Ltd.
Royal Brisbane and Women's Hospital
Siriraj Hospital
Tan Tock Seng Hospital
University of North Carolina, Chapel Hill

Registry information

Official study title

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

Important dates

Study start: 2022
Primary completion: 2022
Study completion: 2022
First posted: Feb 25, 2022
Registry last updated: May 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed