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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

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
Change History
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 *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
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
Removed Location Countries  
 
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