Infection With Unknown Origin in the Emergency Department

NCT04661085 | Completed

• 1 other identifier: SHS-ED-11f-2020
• Study Type: observational
• Target: 966
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Infection

Keywords

antibiotics; source; diagnosis; fever; pyrexia

Outcome Measures

Primary Outcomes (1)

• Diagnosis after 2 days

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

  48 hours after admission emergency department

Secondary Outcomes (6)

• Intensive care unit treatment

  within 60 days from admission to the emergency department

• Length of stay

  within 60 days from admission to the emergency department

• 30-days mortality

  within 30 days from admission to the emergency department

• Readmission

  within 30 days from day of discharge

• In-hospital mortality

  within 60 days from admission to the emergency department

Other Outcomes (4)

• 90-day mortality

  Within 90 days from admission to emergency department

• Level of infection markers

  Within 4 hours of arrival to emergency department

• Level of markers of lung injury

  Within 4 hours of arrival to emergency department

Study Arms (1)

Patients with a suspected infection

Acutely admitted patients from the emergency department across 3 sites who have a suspected infection.

Diagnostic Test: Broader Medical history and clinical tests

Interventions

Broader Medical history and clinical tests DIAGNOSTIC_TEST

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

Patients with a suspected infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

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.

You may qualify if:

• 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).

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Related Publications (7)

• 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.

  PMID: 24814917 BACKGROUND

• 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.

  PMID: 10794946 BACKGROUND

• 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.

  PMID: 31253624 BACKGROUND

• 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.

  PMID: 31346995 BACKGROUND

• 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.

  PMID: 28526094 BACKGROUND

• 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.

  PMID: 39638587 DERIVED

• 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.

  PMID: 34593497 DERIVED

MeSH Terms

Conditions

Infections; Disease; Fever

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Body Temperature Changes; Signs and Symptoms

Study Officials

• Christian Backer Mogensen

  University Hospital of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 8, 2020
• First Posted: December 9, 2020
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 1, 2022
• Last Updated: September 14, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)