Antibiotic Resistance in Danish EDs.

NCT03352167 | Completed DMC

• 1 other identifier: SHS-ED-11-2017
• Study Type: observational
• Target: 5,117
• Locations: 1 country
• Sites: 8

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.

Conditions

Antibiotic Resistance, Bacterial

Outcome Measures

Primary Outcomes (1)

• Bacterial Antibiotic Resistance

  baseline observation only

Study Arms (8)

ED Hjoerring

ED Aalborg

ED Aarhus

ED Herning

ED Aabenraa

ED Odense

ED Slagelse

ED Koege

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may not qualify if:

• no operation in rectum less than 2 weeks before the admission

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (8)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Aalborg University Hospital

Aalborg, Denmark

Location

Aarhus Univerisity Hospital

Aarhus, Denmark

Location

Herning Hospital

Herning, Denmark

Location

Hjørring Hospital

Hjørring, Denmark

Location

Køge University Hospital

Køge, Denmark

Location

Odense University Hospital

Odense, Denmark

Location

Slagelse Hospital

Slagelse, Denmark

Location

Related Publications (2)

• Skjot-Arkil H, Mogensen CB, Lassen AT, Johansen IS, Chen M, Petersen P, Andersen KV, Ellermann-Eriksen S, Moller 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.

  PMID: 31253624 DERIVED

• Mogensen CB, Skjot-Arkil H, Lassen AT, Johansen IS, Chen M, Petersen P, Andersen KV, Ellermann-Eriksen S, Moller 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.

  PMID: 30126361 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Target Duration: 4 Months
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: ass. professor

Study Record Dates

• First Submitted: November 20, 2017
• First Posted: November 24, 2017
• Study Start: January 8, 2018
• Primary Completion: May 1, 2018
• Study Completion: July 1, 2018
• Last Updated: May 27, 2021

Record last verified: 2021-05

Data Sharing

• IPD Sharing: Will not share

Locations

DK (8)