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

May 18, 2023 updated by: The University of Queensland

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Actual)

790

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Australia
    • Queensland
      • Herston, Queensland, Australia, 4029
        • Royal Brisbane and Women'S Hospital
  • India
      • Vellore, India, 632004
        • Christian medical college
  • Singapore
      • Singapore, Singapore
        • Tan Tock Seng Hospital
  • Thailand
      • Bangkok, Thailand
        • Siriraj Hospital
  • United States
    • North Carolina
      • Chapel Hill, North Carolina, United States, 27599
        • University of North Carolina

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Previously admitted COVID-19 patients admitted to Intensive Care Units

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Previously admitted COVID-19 patients in intensive care units
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
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

What is the study measuring?

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
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
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
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
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.
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
Within the first 60 days of hospital admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The University of Queensland

Collaborators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 14, 2022

Primary Completion (Actual)

December 4, 2022

Study Completion (Actual)

December 4, 2022

Study Registration Dates

First Submitted

February 24, 2022

First Submitted That Met QC Criteria

February 24, 2022

First Posted (Actual)

February 25, 2022

Study Record Updates

Last Update Posted (Actual)

May 22, 2023

Last Update Submitted That Met QC Criteria

May 18, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HREC/2021/QRBW/74171

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on COVID-19

Clinical Trials on Previously admitted COVID-19 patients in intensive care units

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Papua New Guinea

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe