Clinical trial NCT04681963: Clinical Characteristics of Acutely Hospitalized Adults With Community-acquired- Pneumonia
Official title: Clinical Characteristics of Hospitalized Adults With Community-acquired- Pneumonia at the Emergency Department: A Cross-sectional Study
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Pneumonia
Keywords: risk factors
Community acquired pneumonia
Lead sponsor: University of Southern Denmark
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 966
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Acutely admitted patients suspected of community-acquired pneumonia at three hospitals in The Region of Southern Denmark (Hospital Sønderjylland, Hospital Lillebaelt and Odense University Hospital).

Brief summary: There is no gold standard when diagnosing of pneumonia. The variability of clinical signs and symptoms make it difficult to distinguish pneumonia from other causes of respiratory conditions. Well defined characteristics upon arrival to the emergency department will contribute to the better and quicker diagnosis of community-acquired pneumonia.

Detailed description: Currently, pneumonia diagnosis is primarily based on clinical symptoms such as cough, shortness of breath, chest pain, fever and sputum production, combined with X-ray of the lungs, relevant blood tests and microbiological analysis of sputum samples. The X-ray is an imprecise diagnostic tool, and results from sputum assays are first available after 2 days. In the elderly, pneumonia presents with clinically differing signs such as delirium, malnutrition, and there may be an absence of fever, cough and dyspnea. The physical examination is also challenged by a broad variety of atypical symptoms like headache, dry cough and gastrointestinal symptoms in the form of nausea, vomiting or diarrhea. Our hypothesis is that well-defined clinical characteristics upon arrival to the emergency department will contribute to the better and quicker diagnosis of pneumonia.

The aim is to identify the information available upon arrival to the Emergency Department that contributes to diagnosis and prognosis of community-acquired-pneumonia.

The objectives are:

1. Identify the information available upon arrival that correlates to the diagnosis of community-acquired pneumonia
2. Identify the information available upon arrival that correlates to severity of community-acquired pneumonia

Eligibility criteria: Inclusion Criteria:

* Patients \> 18 years old
* Patients suspected with CAP by the attending physician. The physician will base his/her suspicion on e.g. clinical symptoms such as cough, increased sputum production, chest tights, dyspnea and fever\>38C, and indication for x-ray.

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)

Primary outcomes:
measure: Diagnosis of community acquired pneumonia
timeFrame: expert assessment within 3 months after patient discharge from the hospital
Secondary outcomes:
measure: Intensive care unit (ICU) treatment:
timeFrame: within 60 days from admission to the emergency department
measure: Length of hospital stay
timeFrame: within 60 days from current admission to the emergency department
measure: 30-days mortality
timeFrame: 30 days from the admission to the emergency department
measure: Readmission
timeFrame: within 30 days from the discharge to the hospital
measure: In-hospital mortality
timeFrame: within 60 days from admission to the emergency department
Other outcomes:
measure: 90 days mortality
timeFrame: within 90 days from admission to emergency department
measure: CURB-65 score for predicting mortality in community-acquired-pneumonia
timeFrame: within 4 hours from admission
measure: Pneumonia severity index (PSI)
timeFrame: : within 4 hours from admission
measure: Microbial agents
timeFrame: results within 7 days from sputum sample collection
measure: Level of infection markers
timeFrame: results within 4 hour from admission
measure: Level of markers of lung injury
timeFrame: within 4 hours from admission
measure: Bacteriuria
timeFrame: within 4 hours from admission
Locations:
city: Aabenraa
country: Denmark
facility: Hospital of Southern Jutland
Study officials:
affiliation: University Hospital of Southern Denmark
name: Christian Backer Mogensen
role: STUDY_CHAIR
References:
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