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OpenTrials
Completed

NCT Number: NCT04661085

Infection With Unknown Origin in the Emergency Department

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of Southern Jutland

Aabenraa, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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,

Primary outcomes

  1. Diagnosis after 2 days

    Time frame: 48 hours after admission emergency department

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

Secondary outcomes

  1. Intensive care unit treatment

    Time frame: within 60 days from admission to the emergency department

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

  2. Length of stay

    Time frame: within 60 days from admission to the emergency department

    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

  3. 30-days mortality

    Time frame: within 30 days from admission to the emergency department

    Mortality within 30 days from admission to the Emergency Department

  4. Readmission

    Time frame: within 30 days from day of discharge

    Binary

  5. In-hospital mortality

    Time frame: within 60 days from admission to the emergency department

    binary

  6. Diagnose code at hospital discharge

    Time frame: within 60 days from admission to the emergency department

    code registered in medical record at discharge

Other outcomes

  1. 90-day mortality

    Time frame: Within 90 days from admission to emergency department

    Mortality - binary

  2. Level of infection markers

    Time frame: Within 4 hours of arrival to emergency department

    concentration of serum procalcitonin, CRP and suPAR

  3. Level of markers of lung injury

    Time frame: Within 4 hours of arrival to emergency department

    concentration of serum surfactant protein D, KL-6, and YKL-40

  4. Bacteriuria

    Time frame: Within 4 hours of arrival to emergency department

    defined by microbiologist on urine culture analysis

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 9, 2020
Registry last updated
Sep 14, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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