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Infection With Unknown Origin in the Emergency Department

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04661085
Enrollment
966
Registered
2020-12-09
Start date
2021-03-01
Completion date
2022-06-01
Last updated
2022-09-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infection

Keywords

antibiotics, source, diagnosis, fever, pyrexia

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.

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.

Interventions

DIAGNOSTIC_TESTBroader Medical history and clinical tests

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

Sponsors

University of Southern Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

* 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)

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis after 2 days48 hours after admission emergency departmentDiagnosis code of patient (registered medical record and clinical expert panel assessment)

Secondary

MeasureTime frameDescription
Length of staywithin 60 days from admission to the emergency departmentDefined 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
30-days mortalitywithin 30 days from admission to the emergency departmentMortality within 30 days from admission to the Emergency Department
Readmissionwithin 30 days from day of dischargeBinary
In-hospital mortalitywithin 60 days from admission to the emergency departmentbinary
Diagnose code at hospital dischargewithin 60 days from admission to the emergency departmentcode registered in medical record at discharge
Intensive care unit treatmentwithin 60 days from admission to the emergency departmentTransfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred)

Other

MeasureTime frameDescription
Level of markers of lung injuryWithin 4 hours of arrival to emergency departmentconcentration of serum surfactant protein D, KL-6, and YKL-40
BacteriuriaWithin 4 hours of arrival to emergency departmentdefined by microbiologist on urine culture analysis
Level of infection markersWithin 4 hours of arrival to emergency departmentconcentration of serum procalcitonin, CRP and suPAR
90-day mortalityWithin 90 days from admission to emergency departmentMortality - binary

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026