Infection With Unknown Origin in the Emergency Department

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04661085
• Other study ID #: SHS-ED-11f-2020
• Status: Completed
• Start date: March 1, 2021
• Est. completion date: June 1, 2022

Study information

• Verified date: September 2022
• Source: University of Southern Denmark
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 966
• Est. completion date: June 1, 2022
• Est. primary completion date: February 28, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Communicable Diseases
• Emergencies
• Infection
• Infections

Intervention

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,

Locations

Country	Name	City	State
Denmark	Hospital of Southern Jutland	Aabenraa

Sponsors (1)

Lead Sponsor	Collaborator
University of Southern Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (5)

Bager F. DANMAP: monitoring antimicrobial resistance in Denmark. Int J Antimicrob Agents. 2000 May;14(4):271-4. — View Citation

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. — View Citation

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. — View Citation

Skjøt-Arkil H, Mogensen CB, Lassen AT, Johansen IS, Chen M, Petersen P, Andersen KV, Ellermann-Eriksen S, Møller 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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	90-day mortality	Mortality - binary	Within 90 days from admission to emergency department
Other	Level of infection markers	concentration of serum procalcitonin, CRP and suPAR	Within 4 hours of arrival to emergency department
Other	Level of markers of lung injury	concentration of serum surfactant protein D, KL-6, and YKL-40	Within 4 hours of arrival to emergency department
Other	Bacteriuria	defined by microbiologist on urine culture analysis	Within 4 hours of arrival to emergency department
Primary	Diagnosis after 2 days	Diagnosis code of patient (registered medical record and clinical expert panel assessment)	48 hours after admission emergency department
Secondary	Intensive care unit treatment	Transfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred)	within 60 days from admission to the emergency department
Secondary	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	within 60 days from admission to the emergency department
Secondary	30-days mortality	Mortality within 30 days from admission to the Emergency Department	within 30 days from admission to the emergency department
Secondary	Readmission	Binary	within 30 days from day of discharge
Secondary	In-hospital mortality	binary	within 60 days from admission to the emergency department
Secondary	Diagnose code at hospital discharge	code registered in medical record at discharge	within 60 days from admission to the emergency department