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InfectionNCT04661085

Infection With Unknown Origin in the Emergency Department

An observational study of Infection, run by University of Southern Denmark at 1 site in Denmark.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Patients suspected with infection is one of the major groups, who are admitted to the Danish Emergency Departments (ED). Currently, there is no overall description of the distribution of these infections. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Infection
What is being tested?
Broader Medical history and clinical tests
How many people
966 participants
Where
1 siteDenmark
Study dates
1 Mar 2021to 1 Jun 2022
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: Acutely admitted patients suspected with infection at three hospitals in the region of Southern Denmark - Hosptial Sonderjylland, Hospital Lillebaelt and Odense University Hospital.

Who may be able to join

  • Adults admitted to the ED will be invited to participate in the study, if the physician, receiving the patient, suspect the patient has an infection (e.g. indication for blood culture).

Who cannot join

  • If the attending physician considers that participation will delay a life-saving treatment or patient needs direct transfer to the intensive care unit.
  • Admission within the last 14 days
  • Verified COVID-19 disease within 14 days before admission
  • Pregnant women
  • Severe immunodeficiencies: Primary immunodeficiencies and secondary immunodeficiencies (HIV positive CD4 <200, Patients receiving immunosuppressive treatment (ATC L04A), Corticosteroid treatment (>20 mg/day prednisone or equivalent for >14 days within the last 30 days), Chemotherapy within 30 days)

Trial locations and contacts

1 site in 1 country.

Denmark1 site

  • Hospital of Southern Jutland

    Aabenraa

Other trials in Denmark

About this study

Official title: A Descriptive Study of Patients Suspected With Infection in the Emergency Department, With a Special Focus on Infection With Unknown Origin.

Patients suspected with infection is one of the major groups, who are admitted to the Danish Emergency Departments (ED). Currently, there is no overall description of the distribution of these infections. The aim of this study is to characterize ED patients with a suspected infection whereby the focus of the infection is of an unknown origin.

Read the detailed description

Bacteria resistant to antibiotics are associated with high antibiotic consumption and are identified by the World Health Organisation as a major public health threat. Despite efforts to optimize antibiotic consumption in Denmark, the total consumption in the hospital sector increased from 2009-2018 and the incidence of multi-resistance bacteria (MRB) is increasing. A Danish multicenter study has shown that every 20th patient in the emergency department has MRB. Patients with an infection of unknown origin tend to be prescribed a broad-spectrum antibiotic, as physicians endeavour to target probable origins in the body. The uncertainty associated with the diagnosis may lead to an overconsumption of antibiotics, which contributes to increased development of resistant bacteria and threatens future treatment options.

The aim of this study is to characterize patients admitted to the ED suspected with infection. The study will have three objectives:

  • To describe the distribution of ED infections according to the registered diagnosis in the medical record compared to a clinical expert panel assessment
  • To identify clinically relevant information available at admission associated with a patients infection of unknown origin.
  • To investigate the association between an adverse event and clinically relevant information for patients with infection of unknown origin

The investigators' hypothesis is that with an improvement of knowledge about patients with an infection of unknown origin, a more accurate diagnosis can be made leading to a more appropriate antibiotic therapy and contributing to the fight against resistance to antibiotics.

Conditions
Infection
Being tested
Broader Medical history and clinical tests
Keywords
antibiotics, source, diagnosis, fever, pyrexia
Medical subject headings
Infections, Disease, Fever

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Broader Medical history and clinical testsDiagnostic test

    Patients will be treated with standard care plus additional blood tests, urine culture and urine flow cytometry,

Study groups in NCT04661085
Study groupRoleWhat they receive
Patients with a suspected infectionAcutely admitted patients from the emergency department across 3 sites who have a suspected infection.
Receives: Diagnostic Test: Broader Medical history and clinical tests

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Diagnosis after 2 days

    Diagnosis code of patient (registered medical record and clinical expert panel assessment)

    Measured: 48 hours after admission emergency department

Secondary outcomes (6)

  1. Intensive care unit treatment

    Transfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred)

    Measured: within 60 days from admission to the emergency department

  2. Length of stay

    Defined as the time (in days) spent in hospital during the current admission. Measured in days from admission to hospital discharge. Discharge date minus admission date

    Measured: within 60 days from admission to the emergency department

  3. 30-days mortality

    Mortality within 30 days from admission to the Emergency Department

    Measured: within 30 days from admission to the emergency department

  4. Readmission

    Binary

    Measured: within 30 days from day of discharge

  5. In-hospital mortality

    binary

    Measured: within 60 days from admission to the emergency department

  6. Diagnose code at hospital discharge

    code registered in medical record at discharge

    Measured: within 60 days from admission to the emergency department

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2020
  2. Study start1 Mar 2021
  3. Primary completion28 Feb 2022
  4. Study completion1 Jun 2022

Resources

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
966 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04661085
Sponsor's protocol ID
SHS-ED-11f-2020
Status last verified
Sep 2022
First submitted
8 Dec 2020
Last updated
14 Sep 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Carter-Storch R, Olsen UF, Mogensen CB. Admissions to emergency department may be classified into specific complaint categories. Dan Med J. 2014 Mar;61(3):A4802.

    PubMed 24814917

  • Bager F. DANMAP: monitoring antimicrobial resistance in Denmark. Int J Antimicrob Agents. 2000 May;14(4):271-4. doi: 10.1016/s0924-8579(00)00135-7.

    PubMed 10794946

  • 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 31253624

  • Zhao MZ, Ruan QR, Xing MY, Wei S, Xu D, Wu ZH, Zhu L, Zhu JL, Zheng CF, Liu S, Yu ZJ, Qi JY, Song JX. A Diagnostic Tool for Identification of Etiologies of Fever of Unknown Origin in Adult Patients. Curr Med Sci. 2019 Aug;39(4):589-596. doi: 10.1007/s11596-019-2078-3. Epub 2019 Jul 25.

    PubMed 31346995

  • Courjon J, Demonchy E, Degand N, Risso K, Ruimy R, Roger PM. Patients with community-acquired bacteremia of unknown origin: clinical characteristics and usefulness of microbiological results for therapeutic issues: a single-center cohort study. Ann Clin Microbiol Antimicrob. 2017 May 19;16(1):40. doi: 10.1186/s12941-017-0214-0.

    PubMed 28526094

  • Skjot-Arkil H, Cartuliares MB, Heltborg A, Lorentzen MH, Hertz MA, Kaldan F, Specht JJ, Graumann O, Lindberg MJH, Mikkelsen PA, Nielsen SL, Jensen J, Roge BT, Rosenvinge FS, Mogensen CB. Clinical characteristics and diagnostic accuracy of preliminary diagnoses in adults with infections in Danish emergency departments: a multicentre combined cross-sectional and diagnostic study. BMJ Open. 2024 Dec 5;14(12):e090259. doi: 10.1136/bmjopen-2024-090259.

    PubMed 39638587

  • Skjot-Arkil H, Heltborg A, Lorentzen MH, Cartuliares MB, Hertz MA, Graumann O, Rosenvinge FS, Petersen ERB, Ostergaard C, Laursen CB, Skovsted TA, Posth S, Chen M, Mogensen CB. Improved diagnostics of infectious diseases in emergency departments: a protocol of a multifaceted multicentre diagnostic study. BMJ Open. 2021 Sep 30;11(9):e049606. doi: 10.1136/bmjopen-2021-049606.

    PubMed 34593497

Questions about this trial

What is this clinical trial studying?

An observational study of Infection, run by University of Southern Denmark at 1 site 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 1 inclusion and 5 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 14 Sep 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site 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?

Diagnosis after 2 days (time frame: 48 hours after admission emergency department). 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 NCT04661085, which also lists 7 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 14 Sep 2022.

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