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

NCT ID: NCT05256316

Last Updated: 2023-05-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

790 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-02-14

Study Completion Date

2022-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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COVID-19

Study Design

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Observational Model Type

COHORT

Study Time Perspective

RETROSPECTIVE

Study Groups

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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.

Previously admitted COVID-19 patients in intensive care units

Intervention Type OTHER

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

Interventions

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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 Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Merck Sharp & Dhome (Australia) Pty. Ltd.

UNKNOWN

Sponsor Role collaborator

Christian Medical College, Vellore, India

OTHER

Sponsor Role collaborator

Tan Tock Seng Hospital

OTHER

Sponsor Role collaborator

Royal Brisbane and Women's Hospital

OTHER_GOV

Sponsor Role collaborator

Siriraj Hospital

OTHER

Sponsor Role collaborator

University of North Carolina, Chapel Hill

OTHER

Sponsor Role collaborator

The University of Queensland

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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University of North Carolina

Chapel Hill, North Carolina, United States

Site Status

Royal Brisbane and Women's Hospital

Herston, Queensland, Australia

Site Status

Christian Medical College

Vellore, , India

Site Status

Tan Tock Seng Hospital

Singapore, , Singapore

Site Status

Siriraj Hospital

Bangkok, , Thailand

Site Status

Countries

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United States Australia India Singapore Thailand

Other Identifiers

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HREC/2021/QRBW/74171

Identifier Type: -

Identifier Source: org_study_id

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