Clinical trial NCT05256316: Risks of Bacterial and Fungal Superinfection in Patients With COVID-19
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: COVID-19
Keywords: secondary infections
bacterial infections
fungal infections
Lead sponsor: The University of Queensland
Sponsor class: OTHER
Collaborators: name: Merck Sharp & Dhome (Australia) Pty. Ltd.
name: Christian Medical College, Vellore, India
name: Tan Tock Seng Hospital
name: Royal Brisbane and Women's Hospital
name: Siriraj Hospital
name: University of North Carolina, Chapel Hill
First posted: 2022-02-25
Enrollment: 790
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: RETROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Previously admitted COVID-19 patients admitted to Intensive Care Units

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.


Eligibility criteria: 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

Primary outcomes:
measure: Describe the incidence, management and outcomes of secondary infections in COVID-19 patients admitted to intensive care units
timeFrame: Within the first 60 days of hospital admission
measure: Compare clinical and microbiological outcomes based on treatment appropriateness in COVID-19 patients admitted to intensive care units
timeFrame: Within the first 60 days of hospital admission
measure: Assess the use and effect of immune suppression in COVID-19 patients admitted to intensive care units.
timeFrame: Within the first 60 days of hospital admission
Secondary outcomes:
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: University of North Carolina
state: North Carolina
city: Herston
country: Australia
facility: Royal Brisbane and Women's Hospital
state: Queensland
city: Vellore
country: India
facility: Christian Medical College
city: Singapore
country: Singapore
facility: Tan Tock Seng Hospital
city: Bangkok
country: Thailand
facility: Siriraj Hospital
Study officials:
References: