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

NCT05256316 | Completed

• 1 other identifier: HREC/2021/QRBW/74171
• Study Type: observational
• Target: 790
• Locations: 5 countries
• Sites: 5

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.

Conditions

COVID-19

Keywords

secondary infections; bacterial infections; fungal infections

Outcome Measures

Primary Outcomes (3)

• 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

Study Arms (1)

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

Interventions

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

Previously admitted COVID-19 patients in intensive care units

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Previously admitted COVID-19 patients admitted to Intensive Care Units

You may qualify if:

• 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

You may not qualify if:

• Hospital admission shorter than 5 days
• Persons younger than 18 years of age

Sponsors & Collaborators

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

Study Sites (5)

University of North Carolina

Chapel Hill, North Carolina, 27599, United States

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Christian Medical College

Vellore, 632004, India

Location

Tan Tock Seng Hospital

Singapore, Singapore

Location

Siriraj Hospital

Bangkok, Thailand

Location

MeSH Terms

Conditions

COVID-19; Coinfection; Bacterial Infections; Mycoses

Interventions

Intensive Care Units

Condition Hierarchy (Ancestors)

Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Bacterial Infections and Mycoses

Intervention Hierarchy (Ancestors)

Hospital Units; Health Facilities; Health Care Facilities Workforce and Services

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 24, 2022
• First Posted: February 25, 2022
• Study Start: February 14, 2022
• Primary Completion: December 4, 2022
• Study Completion: December 4, 2022
• Last Updated: May 22, 2023

Record last verified: 2022-02

Locations

US (1); TH (1); AU (1); SG (1); IN (1)