Trial Review

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
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
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
Secondary ID [1] 0 0
HREC/2021/QRBW/74171
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
COVID-19 0 0
Condition category
Condition code
Infection 0 0 0 0
Other infectious diseases
Respiratory 0 0 0 0
Other respiratory disorders / diseases

Intervention/exposure
Study type
Observational
Patient registry
Target follow-up duration
Target follow-up type
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
Intervention code [1] 0 0
Other interventions
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Describe the incidence, management and outcomes of secondary infections in COVID-19 patients admitted to intensive care units
Timepoint [1] 0 0
Within the first 60 days of hospital admission
Primary outcome [2] 0 0
Compare clinical and microbiological outcomes based on treatment appropriateness in COVID-19 patients admitted to intensive care units
Timepoint [2] 0 0
Within the first 60 days of hospital admission
Primary outcome [3] 0 0
Assess the use and effect of immune suppression in COVID-19 patients admitted to intensive care units.
Timepoint [3] 0 0
Within the first 60 days of hospital admission

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
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
* Hospital admission shorter than 5 days
* Persons younger than 18 years of age

Study design
Purpose
Duration
Selection
Timing
Retrospective
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
14/02/2022
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
4/12/2022
Sample size
Target
Accrual to date
Final
790
Recruitment in Australia
Recruitment state(s)
QLD
Recruitment hospital [1] 0 0
Royal Brisbane and Women's Hospital - Herston
Recruitment postcode(s) [1] 0 0
4029 - Herston
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
North Carolina
Country [2] 0 0
India
State/province [2] 0 0
Vellore
Country [3] 0 0
Singapore
State/province [3] 0 0
Singapore
Country [4] 0 0
Thailand
State/province [4] 0 0
Bangkok

Funding & Sponsors
Primary sponsor type
Other
Name
The University of Queensland
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
Merck Sharp & Dhome (Australia) Pty. Ltd.
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
Christian Medical College, Vellore, India
Address [2] 0 0
Country [2] 0 0
Other collaborator category [3] 0 0
Other
Name [3] 0 0
Tan Tock Seng Hospital
Address [3] 0 0
Country [3] 0 0
Other collaborator category [4] 0 0
Government body
Name [4] 0 0
Royal Brisbane and Women's Hospital
Address [4] 0 0
Country [4] 0 0
Other collaborator category [5] 0 0
Other
Name [5] 0 0
Siriraj Hospital
Address [5] 0 0
Country [5] 0 0
Other collaborator category [6] 0 0
Other
Name [6] 0 0
University of North Carolina, Chapel Hill
Address [6] 0 0
Country [6] 0 0

Ethics approval
Ethics application status

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.
Trial website
https://clinicaltrials.gov/study/NCT05256316
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT05256316