Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03352167
Other study ID # SHS-ED-11-2017
Secondary ID
Status Completed
Phase
First received
Last updated
Start date January 8, 2018
Est. completion date July 1, 2018

Study information

Verified date May 2021
Source University of Southern Denmark
Contact n/a
Is FDA regulated No
Health authority
Study type Observational [Patient Registry]

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 5117
Est. completion date July 1, 2018
Est. primary completion date May 1, 2018
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility - 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

Study Design


Related Conditions & MeSH terms


Locations

Country Name City State
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

Sponsors (1)

Lead Sponsor Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

Outcome

Type Measure Description Time frame Safety issue
Primary Bacterial Antibiotic Resistance baseline observation only