Clinical Characteristics of Acutely Hospitalized Adults With Community-acquired- Pneumonia

Completed

• Conditions: Pneumonia
• Interventions: Other: Clinical Assessment within 4 hours of admission

• Registration Number: NCT04681963
• Lead Sponsor: University of Southern Denmark

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

Study Timeline

• Study First Submitted: 2020-11-23
• Study First Submitted QC: 2020-12-22
• Study First Posted: 2020-12-23
• Study Start: 2021-03-01
• Primary Completion: 2022-02-28
• Study Completion: 2022-06-01
• Status Verified: 2022-09
• Last Update Submitted: 2022-09-15
• Last Update Posted: 2022-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 966

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)

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Suspected pneumonia diagnosis	Clinical Assessment within 4 hours of admission	Acutely admitted patients suspected having pneumonia.

Primary Outcome Measures

Name	Time	Method
Diagnosis of community acquired pneumonia	expert assessment within 3 months after patient discharge from the hospital	The percentage of patients diagnosed with community-acquired pneumonia determined by an expert panel. This outcome measure is a binary variable - verified pneumonia or no pneumonia.; The expert panel consists of two independent consultants from the emergency department with experience in infection and emergency medicine, who individually will determine whether or not the patient admitted with suspected community-acquired pneumonia had the diagnosis. The diagnosis will be based on all available relevant information from the patient medical record within 48 hours from admission including computed tomography. A standardized template will be used. Disagreement will be discussed until a consensus is reached.

Secondary Outcome Measures

Name	Time	Method
Intensive care unit (ICU) 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 hospital stay	within 60 days from current 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	30 days from the admission to the emergency department	Mortality within 30 days from admission to the Emergency Department
Readmission	within 30 days from the discharge to the hospital	If a subject is admitted over a 30 day period after the current hospitalization discharge measured as a binary outcome Re-admissions/not re-admissions.
In-hospital mortality	within 60 days from admission to the emergency department	Patient mortality during the current hospitalization. Binary outcome - Died/ Not died

Trial Locations

Locations (1)

Hospital of Southern Jutland; 🇩🇰 Aabenraa, Denmark