COVID-19NCT05256316
Risks of Bacterial and Fungal Superinfection in Patients With COVID-19
An observational study of COVID-19, run by The University of Queensland at 5 sites in 5 countries.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- COVID-19
- What is being tested?
- Previously admitted COVID-19 patients in intensive care units
- How many people
- 790 participants
- Where
- 5 sitesin 5 countries
- Study dates
- 14 Feb 2022to 4 Dec 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Previously admitted COVID-19 patients admitted to Intensive Care Units
Who may be able to join
- 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
Who cannot join
- Hospital admission shorter than 5 days
- Persons younger than 18 years of age
Trial locations and contacts
5 sites in 5 countries.
5 sites in 5 countries
United States1 site
University of North Carolina
Chapel Hill, North Carolina, 27599
Australia1 site
Royal Brisbane and Women's Hospital
Herston, Queensland, 4029
About this study
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
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
- Being tested
- Previously admitted COVID-19 patients in intensive care units
- Keywords
- secondary infections, bacterial infections, fungal infections
- Medical subject headings
- COVID-19, Coinfection, Bacterial Infections, Mycoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Previously admitted COVID-19 patients in intensive care unitsOther
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
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Previously admitted COVID-19 patients in intensive care units |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: Within the first 60 days of hospital admission
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2022
- Study start14 Feb 2022
- Primary completion4 Dec 2022
- Study completion4 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for COVID-19Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 790 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Queensland
- Sponsor type
- University, hospital or other
- Collaborators
- Merck Sharp & Dhome (Australia) Pty. Ltd., Christian Medical College, Vellore, India, Tan Tock Seng Hospital, Royal Brisbane and Women's Hospital, Siriraj Hospital, University of North Carolina, Chapel Hill
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05256316
- Sponsor's protocol ID
- HREC/2021/QRBW/74171
- Status last verified
- Feb 2022
- First submitted
- 24 Feb 2022
- Last updated
- 22 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05256316
- Acronym / sponsor ID
- HREC/2021/QRBW/74171
- Conditions
- COVID-19
- Keywords
- secondary infections, bacterial infections, fungal infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 790 participants (actual)
- Lead sponsor
- The University of QueenslandUniversity, hospital or other
- Collaborators
- Merck Sharp & Dhome (Australia) Pty. Ltd., Christian Medical College, Vellore, India, Tan Tock Seng Hospital, Royal Brisbane and Women's Hospital, Siriraj Hospital, University of North Carolina, Chapel Hill
- Study start
- 14 Feb 2022 (actual)
- Primary completion
- 4 Dec 2022 (actual)
- Study completion
- 4 Dec 2022 (actual)
- First posted
- 25 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Previously admitted COVID-19 patients in intensive care units | – | Other: Previously admitted COVID-19 patients in intensive care unitsInfectious 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Previously admitted COVID-19 patients admitted to Intensive Care Units
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (2 listed)
- Hospital admission shorter than 5 days
- Persons younger than 18 years of age
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Previously admitted COVID-19 patients in intensive care unitsExposure: 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 | Other | Previously admitted COVID-19 patients in intensive care units |
Primary outcome
Describe the incidence, management and outcomes of secondary infections in COVID-19 patients admitted to intensive care units
Time frame: 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
Time frame: 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.
Time frame: 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
5 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of COVID-19, run by The University of Queensland at 5 sites in 5 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 22 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 sites in United States, Australia, India, Singapore, Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Describe the incidence, management and outcomes of secondary infections in COVID-19 patients admitted to intensive care units (time frame: Within the first 60 days of hospital admission). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2023.