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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
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment
Pneumonia Other: Clinical Assessment within 4 hours of admission

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

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Study Type : Observational
Estimated Enrollment : 400 participants
Observational Model: Cohort
Time Perspective: Cross-Sectional
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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Pneumonia

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




Primary Outcome Measures :
  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 Outcome Measures :
  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 Outcome Measures:
  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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).
Criteria

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)

Information from the National Library of Medicine

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


Contacts
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Contact: Mariana Cartuliares +45 23434441 Mariana.Cartuliares@rsyd.dk
Contact: Helene Skjøt-Arkil + 45 7997 1113 Helene.Skjoet-Arkil@rsyd.dk

Locations
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Denmark
Hospital of Southern Jutland Recruiting
Aabenraa, Denmark
Contact: Christian B Mogensen, MD         
Sponsors and Collaborators
University of Southern Denmark
Investigators
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Study Chair: Christian Backer Mogensen University Hospital of Southern Denmark
Publications:

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: University of Southern Denmark
ClinicalTrials.gov Identifier: NCT04681963    
Other Study ID Numbers: SHS-ED-11e-2020
First Posted: December 23, 2020    Key Record Dates
Last Update Posted: November 29, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University of Southern Denmark:
risk factors
Community acquired pneumonia
Additional relevant MeSH terms:
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Pneumonia
Respiratory Tract Infections
Infections
Lung Diseases
Respiratory Tract Diseases