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Completed

NCT Number: NCT04681963

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

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.

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Key information

Conditions

Pneumonia Community-Acquired Infections Community-Acquired Pneumonia Infections Lung Diseases Respiratory Tract Diseases Respiratory Tract Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hospital of Southern Jutland

Aabenraa, Denmark

About this study

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:

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Clinical Assessment within 4 hours of admission

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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)

  2. 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

  3. 30-days mortality

    Time frame: 30 days from the admission to the emergency department

    Mortality within 30 days from admission to the Emergency Department

  4. 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.

  5. 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

Other outcomes

  1. 90 days mortality

    Time frame: within 90 days from admission to emergency department

    binary

  2. 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).

  3. 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)

  4. 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.

  5. 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.

  6. Level of markers of lung injury

    Time frame: within 4 hours from admission

    Concentration of serum surfactant protein D, KL-6 and YKL-40

  7. Bacteriuria

    Time frame: within 4 hours from admission

    Binary outcome defined by the microbiologist on urine culture analysis

Sponsors and collaborators

Lead sponsor

University of Southern Denmark

Other

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
Sep 16, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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