COVID-19/DRI
Research type
Research Study
Full title
Understanding the impact of COVID-19 on bacterial sepsis, antibiotic consumption and stewardship, and antimicrobial resistance
IRAS ID
299985
Contact name
NA CTRG
Contact email
Sponsor organisation
University of Oxford / Clinical Trials and Research Governance
Duration of Study in the UK
1 years, 7 months, 30 days
Research summary
Antimicrobial resistance (AMR) is now recognized as one of the most serious global threats to human health in the 21C. Forecasts predict the increased usage of high-end antimicrobials, lack of microbiological testing, alteration of usual clinical practices and infection control practices during the hight of pandemic COVID-19, are likely to increase the burden of AMR. We designed an observational cohort study to determine the changes of antimicrobial usage, AMR profiles, antimicrobial stewardship, and infection, prevention, and control during pandemic COVID-19 through a global network of hospitals involving 11 countries (Malawi, Bangladesh, India, Nigeria, Iran, Brazil, Turkey, UK, Italy, Switzerland, South Korea).
Patients admitted to intensive care unit, high dependency unit, departments of critical care or specialised COVID isolation wards with optional transit through emergency department presenting and being clinically diagnosed with pneumonia and/or acute respiratory distress syndrome and/or clinical sepsis irrespective of COVID-19 positivity from 01/10/19 (or four months prior to index COVID-19 case at the country level, whichever date occurred first) to 30/11/21 will be included in this study. Our study is mostly a retrospective and retrieving of de-identified (unlinked anonymised) patient data (data on patients’ clinical, biochemical, and radiological parameter, management profiles such as dose, duration, and indication of antimicrobial therapy) as well as hospital data (total number of beds, occupancy rate, staff-patients ratio, ward-specific supply and usage of antimicrobials, IPC policy) and microbiological data on isolated blood and respiratory pathogens. We will not require individual patient consent.
The majority of management will be steered from the Dept of Zoology, University of Oxford. The Primary Care Clinical Trials Unit (PC-CTU) in Oxford will take primary responsibility for data management. A core scientific team, composed of Walsh, Moore, Yu, Farzana (Oxford) and Wellcome Trust representatives (Midega, Shetty), bring a wealth of experience in managing large international projects.
REC name
South Central - Berkshire Research Ethics Committee
REC reference
21/SC/0236
Date of REC Opinion
7 Jul 2021
REC opinion
Favourable Opinion