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

Completed

• Conditions: COVID-19
• Interventions: Other: Previously admitted COVID-19 patients in intensive care units

• Registration Number: NCT05256316
• Lead Sponsor: The University of Queensland

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-02
• Study Start: 2022-02-14
• Study First Submitted: 2022-02-24
• Study First Submitted QC: 2022-02-24
• Study First Posted: 2022-02-25
• Primary Completion: 2022-12-04
• Study Completion: 2022-12-04
• Last Update Submitted: 2023-05-18
• Last Update Posted: 2023-05-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 790

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Previously admitted COVID-19 patients in intensive care units	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.

Primary Outcome Measures

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

Trial Locations

Locations (5)

Christian Medical College; 🇮🇳 Vellore, India

Royal Brisbane and Women's Hospital; 🇦🇺 Herston, Queensland, Australia

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Siriraj Hospital; 🇹🇭 Bangkok, Thailand

University of North Carolina; 🇺🇸 Chapel Hill, North Carolina, United States