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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT05256316
Enrollment
790
Registered
2022-02-25
Start date
2022-02-14
Completion date
2022-12-04
Last updated
2023-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

COVID-19

Keywords

secondary infections, bacterial infections, fungal infections

Brief summary

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.

Interventions

OTHERPreviously admitted COVID-19 patients in intensive care units

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

Sponsors

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

Study design

Observational model
COHORT
Time perspective
RETROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Describe the incidence, management and outcomes of secondary infections in COVID-19 patients admitted to intensive care unitsWithin the first 60 days of hospital admissionData 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 unitsWithin the first 60 days of hospital admissionData 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.Within the first 60 days of hospital admissionData 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

Countries

Australia, India, Singapore, Thailand, United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026