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

September 15, 2022 updated by: University of Southern Denmark

Clinical Characteristics of Hospitalized Adults With Community-acquired- Pneumonia at the Emergency Department: A Cross-sectional Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

966

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
      • Aabenraa, Denmark
        • Hospital of Southern Jutland

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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).

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Cross-Sectional

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Suspected pneumonia diagnosis
Acutely admitted patients suspected having pneumonia.
Other: Clinical Assessment within 4 hours of admission
Demographics, Symptoms, Severity scores (Triage at admission, confusion, urea, respiration, blood pressure, age (CURB 65) and pneumonia severity score (PSI), clinical parameters, blood testing, chest x-rays, comorbidities, electro-cardiogram

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnosis of community acquired pneumonia
Time Frame: 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.
expert assessment within 3 months after patient discharge from the hospital

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intensive care unit (ICU) 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)
within 60 days from admission to the emergency department
Length of hospital stay
Time Frame: 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
within 60 days from current admission to the emergency department
30-days mortality
Time Frame: 30 days from the admission to the emergency department
Mortality within 30 days from admission to the Emergency Department
30 days from the admission to the emergency department
Readmission
Time Frame: 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.
within 30 days from the discharge to the hospital
In-hospital mortality
Time Frame: within 60 days from admission to the emergency department
Patient mortality during the current hospitalization. Binary outcome - Died/ Not died
within 60 days from admission to the emergency department

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
90 days mortality
Time Frame: within 90 days from admission to emergency department
binary
within 90 days from admission to emergency department
CURB-65 score for predicting mortality in community-acquired-pneumonia
Time Frame: within 4 hours from admission
CURB-65 score consists of: Confusion of new onset, Blood Urea nitrogen greater than 7 mmol/L (19 mg/dL), respiratory rate of 30 breaths per minute or greater, blood pressure less than 90 mmHg systolic or diastolic blood pressure 60 mmHg or less and age 65 or older. The score stratify patients to groups 1 (mild pneumonia), 2 (moderate pneumonia) and 3-5 (severe pneumonia).
within 4 hours from admission
Pneumonia severity index (PSI)
Time Frame: : within 4 hours from admission
Risk classes to predict the severity of pneumonia. Scores are given based on demographics, comorbidity, clinical measurements and physical Exam Findings (<70 = Risk Class II, 71-90 = Risk Class III, 91-130 = Risk Class IV, >130 = Risk Class V)
: within 4 hours from admission
Microbial agents
Time Frame: results within 7 days from sputum sample collection
Microbial agents (bacteria and viruses) identified in standard culture, PCR and multiplex PCR. Sputum samples are collected within 1 hour from patient admission. Descriptive findings in percentage will be registered.
results within 7 days from sputum sample collection
Level of infection markers
Time Frame: results within 4 hour from admission
Concentration of serum PCT and suPAR are collected in connection to routine blood tests within 1 hour from admission.
results within 4 hour from admission
Level of markers of lung injury
Time Frame: within 4 hours from admission
Concentration of serum surfactant protein D, KL-6 and YKL-40
within 4 hours from admission
Bacteriuria
Time Frame: within 4 hours from admission
Binary outcome defined by the microbiologist on urine culture analysis
within 4 hours from admission

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Southern Denmark

Investigators

  • Study Chair: Christian Backer Mogensen, University Hospital of Southern Denmark

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 1, 2021

Primary Completion (Actual)

February 28, 2022

Study Completion (Actual)

June 1, 2022

Study Registration Dates

First Submitted

November 23, 2020

First Submitted That Met QC Criteria

December 22, 2020

First Posted (Actual)

December 23, 2020

Study Record Updates

Last Update Posted (Actual)

September 16, 2022

Last Update Submitted That Met QC Criteria

September 15, 2022

Last Verified

September 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHS-ED-11e-2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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