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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/study/NCT05256316
Registration number
NCT05256316
Ethics application status
Date submitted
24/02/2022
Date registered
25/02/2022
Date last updated
22/05/2023
Titles & IDs
Public title
Risks of Bacterial and Fungal Superinfection in Patients With COVID-19
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Scientific 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
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Secondary ID [1]
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HREC/2021/QRBW/74171
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
COVID-19
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Condition category
Condition code
Infection
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Other infectious diseases
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Respiratory
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Other respiratory disorders / diseases
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Intervention/exposure
Study type
Observational
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Patient registry
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Target follow-up duration
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Target follow-up type
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Description of intervention(s) / exposure
Other interventions - 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.
Other interventions: 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
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Intervention code [1]
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Other interventions
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Describe the incidence, management and outcomes of secondary infections in COVID-19 patients admitted to intensive care units
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Assessment method [1]
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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
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Timepoint [1]
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Within the first 60 days of hospital admission
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Primary outcome [2]
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Compare clinical and microbiological outcomes based on treatment appropriateness in COVID-19 patients admitted to intensive care units
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Assessment method [2]
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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
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Timepoint [2]
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Within the first 60 days of hospital admission
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Primary outcome [3]
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Assess the use and effect of immune suppression in COVID-19 patients admitted to intensive care units.
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Assessment method [3]
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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
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Timepoint [3]
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Within the first 60 days of hospital admission
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Eligibility
Key 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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
* Hospital admission shorter than 5 days
* Persons younger than 18 years of age
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Study design
Purpose
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Duration
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Selection
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Timing
Retrospective
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
14/02/2022
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
4/12/2022
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Sample size
Target
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Accrual to date
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Final
790
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Recruitment in Australia
Recruitment state(s)
QLD
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Recruitment hospital [1]
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Royal Brisbane and Women's Hospital - Herston
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Recruitment postcode(s) [1]
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4029 - Herston
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Recruitment outside Australia
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United States of America
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State/province [1]
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North Carolina
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Country [2]
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India
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State/province [2]
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Vellore
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Country [3]
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Singapore
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State/province [3]
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Singapore
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Country [4]
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Thailand
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State/province [4]
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Bangkok
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Funding & Sponsors
Primary sponsor type
Other
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Name
The University of Queensland
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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Merck Sharp & Dhome (Australia) Pty. Ltd.
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Address [1]
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Other collaborator category [2]
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Other
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Name [2]
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Christian Medical College, Vellore, India
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Address [2]
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Other collaborator category [3]
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Other
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Name [3]
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Tan Tock Seng Hospital
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Address [3]
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Other collaborator category [4]
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Government body
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Name [4]
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Royal Brisbane and Women's Hospital
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Address [4]
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Country [4]
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Other collaborator category [5]
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Other
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Name [5]
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Siriraj Hospital
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Address [5]
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Other collaborator category [6]
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Other
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Name [6]
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University of North Carolina, Chapel Hill
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Address [6]
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Country [6]
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Ethics approval
Ethics application status
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Summary
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.
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Trial website
https://clinicaltrials.gov/study/NCT05256316
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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Address
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Address
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Phone
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Fax
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Email
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Contact person for scientific queries
No information has been provided regarding IPD availability
What supporting documents are/will be available?
No Supporting Document Provided
Results publications and other study-related documents
No documents have been uploaded by study researchers.
Results not provided in
https://clinicaltrials.gov/study/NCT05256316
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