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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04681963
Enrollment
966
Registered
2020-12-23
Start date
2021-03-01
Completion date
2022-06-01
Last updated
2022-09-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pneumonia

Keywords

risk factors, Community acquired pneumonia

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

Interventions

OTHERClinical 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

Sponsors

University of Southern Denmark
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Diagnosis of community acquired pneumoniaexpert assessment within 3 months after patient discharge from the hospitalThe 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

MeasureTime frameDescription
Intensive care unit (ICU) treatment:within 60 days from admission to the emergency departmentTransfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred)
Length of hospital staywithin 60 days from current admission to the emergency departmentDefined 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 mortality30 days from the admission to the emergency departmentMortality within 30 days from admission to the Emergency Department
Readmissionwithin 30 days from the discharge to the hospitalIf 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 mortalitywithin 60 days from admission to the emergency departmentPatient mortality during the current hospitalization. Binary outcome - Died/ Not died

Other

MeasureTime frameDescription
90 days mortalitywithin 90 days from admission to emergency departmentbinary
Bacteriuriawithin 4 hours from admissionBinary outcome defined by the microbiologist on urine culture analysis
CURB-65 score for predicting mortality in community-acquired-pneumoniawithin 4 hours from admissionCURB-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).
Pneumonia severity index (PSI): within 4 hours from admissionRisk 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)
Microbial agentsresults within 7 days from sputum sample collectionMicrobial 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.
Level of infection markersresults within 4 hour from admissionConcentration of serum PCT and suPAR are collected in connection to routine blood tests within 1 hour from admission.
Level of markers of lung injurywithin 4 hours from admissionConcentration of serum surfactant protein D, KL-6 and YKL-40

Countries

Denmark

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 14, 2026