Infection With Unknown Origin in the Emergency Department

Sponsor

University of Southern Denmark (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT04661085

Collaborator

(none)

1,000

Enrollment

Location

Anticipated Duration (Months)

62.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Infection	Diagnostic Test: Broader Medical history and clinical tests

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.

Study Design

Study Type:

Observational

Anticipated Enrollment :

1000 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Mar 1, 2021

Actual Primary Completion Date :

Feb 28, 2022

Anticipated Study Completion Date :

Jul 1, 2022

Arms and Interventions

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

Arm

Intervention/Treatment

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

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

Outcome Measures

Primary Outcome Measures

Diagnosis after 2 days [48 hours after admission emergency department]
Diagnosis code of patient (registered medical record and clinical expert panel assessment)

Secondary Outcome Measures

Intensive care unit treatment [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)
Length of stay [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
30-days mortality [within 30 days from admission to the emergency department]
Mortality within 30 days from admission to the Emergency Department
Readmission [within 30 days from day of discharge]
Binary
In-hospital mortality [within 60 days from admission to the emergency department]
binary
Diagnose code at hospital discharge [within 60 days from admission to the emergency department]
code registered in medical record at discharge

Other Outcome Measures

90-day mortality [Within 90 days from admission to emergency department]
Mortality - binary
Level of infection markers [Within 4 hours of arrival to emergency department]
concentration of serum procalcitonin, CRP and suPAR
Level of markers of lung injury [Within 4 hours of arrival to emergency department]
concentration of serum surfactant protein D, KL-6, and YKL-40
Bacteriuria [Within 4 hours of arrival to emergency department]
defined by microbiologist on urine culture analysis

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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)