Antibiotic Resistance in Danish EDs. (AB-RED)

• ClinicalTrials.gov Identifier: NCT03352167
• Recruitment Status: Completed
• First Posted: November 24, 2017
• Last Update Posted: May 27, 2021
• Sponsor: University of Southern Denmark
• Information provided by (Responsible Party): Christian Backer Mogensen, University of Southern Denmark

Tracking Information

• First Submitted Date: November 20, 2017
• First Posted Date: November 24, 2017
• Last Update Posted Date: May 27, 2021
• Actual Study Start Date: January 8, 2018
• Actual Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)
• Current Primary Outcome Measures (submitted: November 20, 2017): Bacterial Antibiotic Resistance [ Time Frame: baseline observation only ]
• Original Primary Outcome Measures: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Antibiotic Resistance in Danish EDs.
• Official Title: Antibiotic Resistance in Danish Emergency Departments. Prevalence, Risk Factors and Definition of Risk Groups.

Brief Summary

The spread of multiresistant bacteria is an increasing problem which will mean increased costs, morbidity and mortality in the coming years. Emergency departments (ED) play a key role in the early identification and management of patients who are carriers of multiresistant bacteria, but today there is very limited knowledge about both prevalence in the EDs and risk factors for the carrier status of methicillin resistant Staphylococcus aureus (MRSA), extended spectrum beta lactam producing enterobacteria (ESBL), vancomycin resistant enterococci (VRE), carbapenem resistant enterobacteria (CPE) and toxin-producing Clostridium difficile (CD). This knowledge is necessary to prioritize and target the preventive response to the spread of multiresistant bacteria.

The aim of this project is to provide a comprehensive overview of prevalence and risk factors for carrier status at a national level, and to develop screening tools for early identification of MRSA, ESBL, VRE, CPE and CD carriers among patients admitted to Danish emergency departments.

For hospitalized patients in 8 emergency departments in 4 Danish regions, a total of 10,600 patients are asked for possible risk factors for resistant bacterial carrier status, and are swabbed in the throat, nose and rectum openings and examined for MRSA, VRE, CPE, ESBL and CD with the same analytical method of 4 clinical microbiological departments.

The results are analyzed so that the prevalence of resistant bacteria can be described at the hospital level, regional level and national level. Risk factors are analyzed for applicability for carrier identification, and based on this, screening models for the identification of carriers are developed.

The vision for the project is that, based on the collected data, a comprehensive picture of the extent of the problem in Denmark can be drawn up and new screening tools for early identification of carriers can be developed so that the intra-hospital spread of resistant bacteria can be met through early intervention with infectious hygiene measures.

The project has been granted a grant of DKK 3,000,000 from the Ministry of Health and the Elderly on December 7, 2016 and DKK 554,871 from the Region of Southern Denmark on 28 August 2017.

• Detailed Description: Not Provided
• Study Type: Observational [Patient Registry]
• Study Design: Observational Model: Cohort; Time Perspective: Cross-Sectional
• Target Follow-Up Duration: 4 Months

Biospecimen

Retention:   Samples With DNA

Description:

swabs from nose, throat and rectum for analysis of bacterial DNA

• Sampling Method: Non-Probability Sample
• Study Population: all patients more than 18 years of age admitted for any reason to one of the participating Emergency Departments
• Condition: Antibiotic Resistance, Bacterial
• Intervention: Not Provided

Study Groups/Cohorts

• ED Hjoerring
• ED Aalborg
• ED Aarhus
• ED Herning
• ED Aabenraa
• ED Odense
• ED Slagelse
• ED Koege

Publications *

• Skjøt-Arkil H, Mogensen CB, Lassen AT, Johansen IS, Chen M, Petersen P, Andersen KV, Ellermann-Eriksen S, Møller JM, Ludwig M, Fuglsang-Damgaard D, Nielsen FE, Petersen DB, Jensen US, Rosenvinge FS. Carrier prevalence and risk factors for colonisation of multiresistant bacteria in Danish emergency departments: a cross-sectional survey. BMJ Open. 2019 Jun 27;9(6):e029000. doi: 10.1136/bmjopen-2019-029000.
• Mogensen CB, Skjøt-Arkil H, Lassen AT, Johansen IS, Chen M, Petersen P, Andersen KV, Ellermann-Eriksen S, Møller JM, Ludwig M, Fuglsang-Damgaard D, Nielsen F, Petersen DB, Jensen US, Rosenvinge FS. Cross sectional study of multiresistant bacteria in Danish emergency departments: prevalence, patterns and risk factors for colonization (AB-RED project). BMC Emerg Med. 2018 Aug 20;18(1):25. doi: 10.1186/s12873-018-0178-1.

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: November 9, 2020): 5117
• Original Estimated Enrollment (submitted: November 20, 2017): 10400
• Actual Study Completion Date: July 1, 2018
• Actual Primary Completion Date: May 1, 2018 (Final data collection date for primary outcome measure)

Eligibility Criteria

• Must be over 18 years
• Must be admitted to one of the emergency departments selected for the project for more than 4 hours.
• Must be mentally competent
• To consent to participate

Exclusion Criteria:

• admitted more than 16 hours before inclusion
• no operation in rectum less than 2 weeks before the admission

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Denmark

Administrative Information

• NCT Number: NCT03352167
• Other Study ID Numbers: SHS-ED-11-2017
• Has Data Monitoring Committee: Yes

U.S. FDA-regulated Product

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

• Plan to Share IPD: No

• Responsible Party: Christian Backer Mogensen, University of Southern Denmark
• Study Sponsor: University of Southern Denmark
• Collaborators: Not Provided
• Investigators: Not Provided
• PRS Account: University of Southern Denmark
• Verification Date: May 2021