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

COVID-19 Clinical Trial

Official 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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05256316
• Other study ID #: HREC/2021/QRBW/74171
• Status: Completed
• Start date: February 14, 2022
• Est. completion date: December 4, 2022

Study information

• Verified date: February 2022
• Source: The University of Queensland
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 790
• Est. completion date: December 4, 2022
• Est. primary completion date: December 4, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• COVID-19

Intervention

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

Locations

Country	Name	City	State
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
India	Christian Medical College	Vellore
Singapore	Tan Tock Seng Hospital	Singapore
Thailand	Siriraj Hospital	Bangkok
United States	University of North Carolina	Chapel Hill	North Carolina

Sponsors (7)

Lead Sponsor	Collaborator
The University of Queensland	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

Countries where clinical trial is conducted

United States,  Australia,  India,  Singapore,  Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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