Clinical Characteristics of Acutely Hospitalized Adults With Community-acquired- Pneumonia
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|ClinicalTrials.gov Identifier: NCT04681963|
Recruitment Status : Recruiting
First Posted : December 23, 2020
Last Update Posted : November 29, 2021
|Condition or disease||Intervention/treatment|
|Pneumonia||Other: Clinical Assessment within 4 hours of admission|
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
|Study Type :||Observational|
|Estimated Enrollment :||400 participants|
|Official Title:||Clinical Characteristics of Hospitalized Adults With Community-acquired- Pneumonia at the Emergency Department: A Cross-sectional Study|
|Actual Study Start Date :||March 1, 2021|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||July 2022|
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
- 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.
- 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)
- 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
- 30-days mortality [ Time Frame: 30 days from the admission to the emergency department ]Mortality within 30 days from 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.
- 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
- 90 days mortality [ Time Frame: within 90 days from admission to emergency department ]binary
- 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).
- 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)
- 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.
- 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.
- Level of markers of lung injury [ Time Frame: within 4 hours from admission ]Concentration of serum surfactant protein D, KL-6 and YKL-40
- Bacteriuria [ Time Frame: within 4 hours from admission ]Binary outcome defined by the microbiologist on urine culture analysis
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04681963
|Contact: Mariana Cartuliares||+45 23434441||Mariana.Cartuliares@rsyd.dk|
|Contact: Helene Skjøt-Arkil||+ 45 7997 1113||Helene.Skjoet-Arkil@rsyd.dk|
|Hospital of Southern Jutland||Recruiting|
|Contact: Christian B Mogensen, MD|
|Study Chair:||Christian Backer Mogensen||University Hospital of Southern Denmark|