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Antibiotic Resistance in Danish EDs. (AB-RED)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03352167
Recruitment Status : Completed
First Posted : November 24, 2017
Last Update Posted : May 27, 2021
Sponsor:
Information provided by (Responsible Party):
Christian Backer Mogensen, University of Southern Denmark

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.


Condition or disease
Antibiotic Resistance, Bacterial

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Study Type : Observational [Patient Registry]
Actual Enrollment : 5117 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
Target Follow-Up Duration: 4 Months
Official Title: Antibiotic Resistance in Danish Emergency Departments. Prevalence, Risk Factors and Definition of Risk Groups.
Actual Study Start Date : January 8, 2018
Actual Primary Completion Date : May 1, 2018
Actual Study Completion Date : July 1, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Group/Cohort
ED Hjoerring
ED Aalborg
ED Aarhus
ED Herning
ED Aabenraa
ED Odense
ED Slagelse
ED Koege



Primary Outcome Measures :
  1. Bacterial Antibiotic Resistance [ Time Frame: baseline observation only ]

Biospecimen Retention:   Samples With DNA
swabs from nose, throat and rectum for analysis of bacterial DNA


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03352167


Locations
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Denmark
Hospital of Southern Jutland
Aabenraa, Denmark
Aalborg University Hospital
Aalborg, Denmark
Aarhus Univerisity Hospital
Aarhus, Denmark
Herning Hospital
Herning, Denmark
Hjørring Hospital
Hjørring, Denmark
Køge University Hospital
Køge, Denmark
Odense University Hospital
Odense, Denmark
Slagelse Hospital
Slagelse, Denmark
Sponsors and Collaborators
University of Southern Denmark
Additional Information:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Christian Backer Mogensen, ass. professor, University of Southern Denmark
ClinicalTrials.gov Identifier: NCT03352167    
Other Study ID Numbers: SHS-ED-11-2017
First Posted: November 24, 2017    Key Record Dates
Last Update Posted: May 27, 2021
Last Verified: May 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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