Antibiotic Resistance, BacterialAB-REDNCT03352167
Antibiotic Resistance in Danish EDs.
An observational study of Antibiotic Resistance, Bacterial, run by University of Southern Denmark at 8 sites in Denmark.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic Resistance, Bacterial
- How many people
- 5,117 participants
- Where
- 8 sitesDenmark
- Study dates
- 8 Jan 2018to 1 Jul 2018
- How long will I take part?
- 4 Months
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: all patients more than 18 years of age admitted for any reason to one of the participating Emergency Departments
Who may be able to join
None listed.
Who cannot join
- admitted more than 16 hours before inclusion
- no operation in rectum less than 2 weeks before the admission
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Denmark8 sites
Hospital of Southern Jutland
Aabenraa
Aalborg University Hospital
Aalborg
Aarhus Univerisity Hospital
Aarhus
Herning Hospital
Herning
Hjørring Hospital
Hjørring
Køge University Hospital
Køge
Odense University Hospital
Odense
Slagelse Hospital
Slagelse
About this study
Official title: Antibiotic Resistance in Danish Emergency Departments. Prevalence, Risk Factors and Definition of Risk Groups.
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.
Read more
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
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| ED Hjoerring | Not described | |
| ED Aalborg | Not described | |
| ED Aarhus | Not described | |
| ED Herning | Not described | |
| ED Aabenraa | Not described | |
| ED Odense | Not described | |
| ED Slagelse | Not described | |
| ED Koege | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Bacterial Antibiotic Resistance
Measured: baseline observation only
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2017
- Study start8 Jan 2018
- Primary completion1 May 2018
- Study completion1 Jul 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Antibiotic Resistance, BacterialStudies of the same condition, open and under way.
- More trials run by University of Southern DenmarkThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 5,117 participants (actual)
- Target duration
- 4 Months
Sponsor and investigators
- Lead sponsor
- University of Southern Denmark
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christian Backer Mogensen, University of Southern Denmark
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03352167
- Sponsor's protocol ID
- SHS-ED-11-2017
- Acronym
- AB-RED
- Status last verified
- May 2021
- First submitted
- 20 Nov 2017
- Last updated
- 27 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 31253624Mogensen 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.
PubMed 30126361
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibiotic Resistance in Danish Emergency Departments. Prevalence, Risk Factors and Definition of Risk Groups.
- ClinicalTrials.gov ID
- NCT03352167
- Acronym / sponsor ID
- AB-RED / SHS-ED-11-2017
- Conditions
- Antibiotic Resistance, Bacterial
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 5,117 participants (actual)
- Lead sponsor
- University of Southern DenmarkUniversity, hospital or other
- Study start
- 8 Jan 2018 (actual)
- Primary completion
- 1 May 2018 (actual)
- Study completion
- 1 Jul 2018 (actual)
- First posted
- 24 Nov 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 4 Months
- Number of arms
- 8
| Arm | Type | Receives |
|---|---|---|
| ED Hjoerring | – | – |
| ED Aalborg | – | – |
| ED Aarhus | – | – |
| ED Herning | – | – |
| ED Aabenraa | – | – |
| ED Odense | – | – |
| ED Slagelse | – | – |
| ED Koege | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- all patients more than 18 years of age admitted for any reason to one of the participating Emergency Departments
Key inclusion criteria (0 listed)
Key exclusion criteria (2 listed)
- admitted more than 16 hours before inclusion
- no operation in rectum less than 2 weeks before the admission
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Bacterial Antibiotic Resistance
Time frame: baseline observation only
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2021.
- Derived from this study: PubMed 31253624Skjot-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.
- Derived from this study: PubMed 30126361Mogensen 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic Resistance, Bacterial, run by University of Southern Denmark at 8 sites in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Bacterial Antibiotic Resistance (time frame: baseline observation only). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03352167, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 May 2021.