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

NCT04681963 | Completed

• 1 other identifier: SHS-ED-11e-2020
• Study Type: observational
• Target: 966
• Locations: 1 country
• Sites: 1

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.

Conditions

Pneumonia

Keywords

risk factors; Community acquired pneumonia

Outcome Measures

Primary Outcomes (1)

• Diagnosis of community acquired pneumonia

  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 Outcomes (5)

• Intensive care unit (ICU) treatment:

  within 60 days from admission to the emergency department

• Length of hospital stay

  within 60 days from current admission to the emergency department

• 30-days mortality

  30 days from the admission to the emergency department

• Readmission

  within 30 days from the discharge to the hospital

• In-hospital mortality

  within 60 days from admission to the emergency department

Other Outcomes (7)

• 90 days mortality

  within 90 days from admission to emergency department

• CURB-65 score for predicting mortality in community-acquired-pneumonia

  within 4 hours from admission

• Pneumonia severity index (PSI)

  : within 4 hours from admission

Study Arms (1)

Suspected pneumonia diagnosis

Acutely admitted patients suspected having pneumonia.

Other: Clinical Assessment within 4 hours of admission

Interventions

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

Suspected pneumonia diagnosis

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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).

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Southern Denmark: lead

Study Sites (1)

Hospital of Southern Jutland

Aabenraa, Denmark

Location

Related Publications (10)

• Torres A, Blasi F, Peetermans WE, Viegi G, Welte T. The aetiology and antibiotic management of community-acquired pneumonia in adults in Europe: a literature review. Eur J Clin Microbiol Infect Dis. 2014 Jul;33(7):1065-79. doi: 10.1007/s10096-014-2067-1. Epub 2014 Feb 15.

  PMID: 24532008 BACKGROUND

• Marti C, Garin N, Grosgurin O, Poncet A, Combescure C, Carballo S, Perrier A. Prediction of severe community-acquired pneumonia: a systematic review and meta-analysis. Crit Care. 2012 Jul 27;16(4):R141. doi: 10.1186/cc11447.

  PMID: 22839689 BACKGROUND

• Musher DM, Roig IL, Cazares G, Stager CE, Logan N, Safar H. Can an etiologic agent be identified in adults who are hospitalized for community-acquired pneumonia: results of a one-year study. J Infect. 2013 Jul;67(1):11-8. doi: 10.1016/j.jinf.2013.03.003. Epub 2013 Mar 19.

  PMID: 23523447 BACKGROUND

• Garau J, Baquero F, Perez-Trallero E, Perez JL, Martin-Sanchez AM, Garcia-Rey C, Martin-Herrero JE, Dal-Re R; NACER Group. Factors impacting on length of stay and mortality of community-acquired pneumonia. Clin Microbiol Infect. 2008 Apr;14(4):322-9. doi: 10.1111/j.1469-0691.2007.01915.x. Epub 2008 Jan 8.

  PMID: 18190569 BACKGROUND

• Metlay JP, Kapoor WN, Fine MJ. Does this patient have community-acquired pneumonia? Diagnosing pneumonia by history and physical examination. JAMA. 1997 Nov 5;278(17):1440-5.

  PMID: 9356004 BACKGROUND

• McLaughlin JM, Khan FL, Thoburn EA, Isturiz RE, Swerdlow DL. Rates of hospitalization for community-acquired pneumonia among US adults: A systematic review. Vaccine. 2020 Jan 22;38(4):741-751. doi: 10.1016/j.vaccine.2019.10.101. Epub 2019 Dec 13.

  PMID: 31843272 BACKGROUND

• Sogaard M, Nielsen RB, Schonheyder HC, Norgaard M, Thomsen RW. Nationwide trends in pneumonia hospitalization rates and mortality, Denmark 1997-2011. Respir Med. 2014 Aug;108(8):1214-22. doi: 10.1016/j.rmed.2014.05.004. Epub 2014 May 20.

  PMID: 24898129 BACKGROUND

• Skjot-Arkil H, Cartuliares MB, Heltborg A, Lorentzen MH, Hertz MA, Kaldan F, Specht JJ, Graumann O, Lindberg MJH, Mikkelsen PA, Nielsen SL, Jensen J, Roge BT, Rosenvinge FS, Mogensen CB. Clinical characteristics and diagnostic accuracy of preliminary diagnoses in adults with infections in Danish emergency departments: a multicentre combined cross-sectional and diagnostic study. BMJ Open. 2024 Dec 5;14(12):e090259. doi: 10.1136/bmjopen-2024-090259.

  PMID: 39638587 DERIVED

• Cartuliares MB, Mogensen CB, Rosenvinge FS, Skovsted TA, Lorentzen MH, Heltborg A, Hertz MA, Kaldan F, Specht JJ, Skjot-Arkil H. Community-acquired pneumonia: use of clinical characteristics of acutely admitted patients for the development of a diagnostic model - a cross-sectional multicentre study. BMJ Open. 2024 May 30;14(5):e079123. doi: 10.1136/bmjopen-2023-079123.

  PMID: 38816044 DERIVED

• Skjot-Arkil H, Heltborg A, Lorentzen MH, Cartuliares MB, Hertz MA, Graumann O, Rosenvinge FS, Petersen ERB, Ostergaard C, Laursen CB, Skovsted TA, Posth S, Chen M, Mogensen CB. Improved diagnostics of infectious diseases in emergency departments: a protocol of a multifaceted multicentre diagnostic study. BMJ Open. 2021 Sep 30;11(9):e049606. doi: 10.1136/bmjopen-2021-049606.

  PMID: 34593497 DERIVED

MeSH Terms

Conditions

Pneumonia; Community-Acquired Pneumonia

Condition Hierarchy (Ancestors)

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

Study Officials

• Christian Backer Mogensen

  University Hospital of Southern Denmark

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 23, 2020
• First Posted: December 23, 2020
• Study Start: March 1, 2021
• Primary Completion: February 28, 2022
• Study Completion: June 1, 2022
• Last Updated: September 16, 2022

Record last verified: 2022-09

Data Sharing

• IPD Sharing: Will not share

Locations

DK (1)