Comprehensive Online Database for Antimicrobial Resistance
Research type
Research Study
Full title
Comprehensive Online Database for Antimicrobial Resistance (CODAR): Creating a Data Source Linking Microbiology Laboratory Data (Including Resistance), Antimicrobial Treatment Information, and Longitudinal Clinical Data for Hospitalised Patients
IRAS ID
316345
Contact name
Timothy Felton
Contact email
Sponsor organisation
Pfizer Inc.
Duration of Study in the UK
1 years, 3 months, 29 days
Research summary
Research Summary
Healthcare professionals are inundated with the emergence of drug-resistant organisms, both in the hospital environment and in the community. According to recent global estimates, this silent epidemic [antimicrobial resistance], is currently a leading cause of death, ahead of HIV, tuberculosis, and malaria. Increasing AMR in the UK will give rise to longer hospital stays and an increase in mortality.Global surveillance studies have provided important information about changes in the spectrum of microbial pathogens and trends in the antimicrobial resistance (AMR) patterns in both nosocomial and community-acquired infections. A continued monitoring of antimicrobial resistance patterns in hospitals, and the communities, is essential to guide effective current and future empirical therapy.
The Comprehensive Online Database for Antimicrobial Resistance [CODAR] is a pilot project which aims to combine microbiology data with clinical data that is stored in the electronic health records [EHR] systems of participating hospitals. A key benefit is the access to near real-time point of care resistance trending at the participating sites, that will be made available to the health care professionals, but currently unavailable at the local hospitals. This, combined with epidemiology, management and outcomes data will aid in improving patient care and save lives.
Summary of Results
Rationale and background: The emergence of drug-resistant organisms is a major concern for healthcare providers and most surveillance studies do not capture sufficient metadata to place isolates in an epidemiologically meaningful context.
Research question and objectives:
The CODAR Pilot study intended to:
1. Establish alternate sources of microbiological surveillance data directly from hospital electronic health records (EHRs) and laboratory information management system (LIMS) 2. Collect epidemiology and patient data in parallel with the microbiology laboratory data for bacterial and fungal pathogens of interest from specified indications.Study design: An observational, retrospective, surveillance study in hospitalised patients.
The data collection period lasted 12 months (February 2023–February 2024).
Microbiological, clinical and epidemiological data were collected through manual data entry at each site then uploaded into the electronic data capture (EDC) database.Setting: 21 hospital sites: India (8), Mexico (3), Saudi Arabia (1; addendum), Spain (1) and the UK (8).
Subjects and study size, including dropouts: 7960 hospitalised adult (≥ 18 years) participants met the inclusion criteria.
Variables and data sources: Data included baseline participant and microbiological data, infection type, antimicrobial treatment, concomitant medications, and clinical outcome.Results: A total of 7344 (92.1%) participant records were complete (i.e., with relevant demographic data, ≥ 1 target pathogen identified, ≥ 1 night of hospitalisation, ≥ 1 infection
type) and included in the analysis.Comorbidities were recorded for 79.7% of participants; commonly, vascular hypertensive disorders in India and the UK. Concomitant medication was recorded for > 90% of participants in Mexico and Spain, compared with < 20% in India and the UK.
E. coli, Klebsiella species, P. aeruginosa, S. aureus and Enterococcus species were commonly identified. Candida species were identified more frequently than other fungal pathogens.
Rates of antimicrobial resistance among the identified pathogens and reported infection types were generally lowest in the UK and highest in India.
Overall, >80% of participants were discharged alive. The infection type with the shortest hospital stay and highest percentage of participants discharged alive was SSSI (94.4%).
The duration of stay was longest for mixed infections, with a comparably lower survival rate (82.1%). For participants with comorbidities, lower percentages were discharged alive in India for A. baumannii LRTI (58.3%–70.8%), K. pneumoniae BSI (69.6%–84.6%) and P. aeruginosa BSI (60.0%–70.0%), and in the UK for P. aeruginosa LRTI (44.4%–78.5%), E. faecium BSI (66.0%–87.5%), and mixed infections involving E. faecium (50.0%–68.4%) and S. aureus (50.0%–75.0%).Higher mortality rates were identified for participants receiving combination therapy with E. faecium mixed infections in the UK (36.0%) and K. pneumoniae BSI in India (35.3%).
Mortality rates were also high for participants receiving changed therapy for E. faecium UTI in the UK (38.1%) and A. baumannii LRTI in India (36.8%).Discussion: The CODAR Pilot study involved the integration of large numbers of clinical and microbiological records, and data extraction, in a large-scale linkage analysis. Valuable data were retrieved on pathogens, infection types and antimicrobial resistance that could guide appropriate antimicrobial use. Any limitations of the study design could be addressed through the design of a large-scale, prospective study.
Has the registry been updated to include summary results?: No
If yes - please enter the URL to summary results:
If no – why not?: The study was not a clinical trial and therefore registration was not required.
Did you follow your dissemination plan submitted in the IRAS application form (Q A51)?: Pending
If yes, describe or provide URLs to disseminated materials:
If pending, date when dissemination is expected: 30/09/2024
If no, explain why you didn't follow it:
Have participants been informed of the results of the study?: No
If yes, describe and/or provide URLs to materials shared and how they were shared:
If pending, date when feedback is expected:
If no, explain why they haven't: The study involved accessing information from site databases. It involved linking microbiology laboratory data (including resistance), antimicrobial treatment information, and longitudinal clinical data for hospitalised patients, collected primarily from hospital electronic health records (EHRs) and laboratory information management systems (LIMS).Data review by the site occurred on the pseudonymised data within the EDC system.
REC name
South East Scotland REC 02
REC reference
22/SS/0096
Date of REC Opinion
25 Nov 2022
REC opinion
Further Information Favourable Opinion