Clinical Characteristics of Acutely Hospitalized Adults With Community-acquired- Pneumonia
15. september 2022 oppdatert av: University of Southern Denmark
Clinical Characteristics of Hospitalized Adults With Community-acquired- Pneumonia at the Emergency Department: A Cross-sectional Study
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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
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
Studietype
Observasjonsmessig
Registrering (Faktiske)
966
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Aabenraa, Danmark
- Hospital of Southern Jutland
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år og eldre (Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Sannsynlighetsprøve
Studiepopulasjon
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).
Beskrivelse
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)
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Tverrsnitt
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
|---|---|
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Suspected pneumonia diagnosis
Acutely admitted patients suspected having pneumonia.
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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
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Diagnosis of community acquired pneumonia
Tidsramme: expert assessment within 3 months after patient discharge from the hospital
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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
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Intensive care unit (ICU) treatment:
Tidsramme: within 60 days from admission to the emergency department
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Transfer to the intensive care unit will be recorded during the current hospitalization as a binary variable (transferred/not-transferred)
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within 60 days from admission to the emergency department
|
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Length of hospital stay
Tidsramme: within 60 days from current admission to the emergency department
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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
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within 60 days from current admission to the emergency department
|
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30-dagers dødelighet
Tidsramme: 30 dager fra innleggelsen til akuttmottaket
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Dødelighet innen 30 dager fra innleggelse til legevakten
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30 dager fra innleggelsen til akuttmottaket
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Gjeninnleggelse
Tidsramme: innen 30 dager fra utskrivning til sykehus
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Dersom et forsøksperson er innlagt over en 30 dagers periode etter gjeldende innleggelse målt som et binært utfall Gjeninnleggelser/ikke gjeninnleggelser.
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innen 30 dager fra utskrivning til sykehus
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Dødelighet på sykehus
Tidsramme: innen 60 dager fra innleggelse i akuttmottaket
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Pasientdødelighet under pågående innleggelse.
Binært utfall - Død/ Ikke død
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innen 60 dager fra innleggelse i akuttmottaket
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
90 days mortality
Tidsramme: within 90 days from admission to emergency department
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binary
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within 90 days from admission to emergency department
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CURB-65 score for predicting mortality in community-acquired-pneumonia
Tidsramme: within 4 hours from admission
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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).
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within 4 hours from admission
|
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Pneumonia severity index (PSI)
Tidsramme: : within 4 hours from admission
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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)
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: within 4 hours from admission
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Microbial agents
Tidsramme: results within 7 days from sputum sample collection
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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.
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results within 7 days from sputum sample collection
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Level of infection markers
Tidsramme: results within 4 hour from admission
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Concentration of serum PCT and suPAR are collected in connection to routine blood tests within 1 hour from admission.
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results within 4 hour from admission
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Level of markers of lung injury
Tidsramme: within 4 hours from admission
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Concentration of serum surfactant protein D, KL-6 and YKL-40
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within 4 hours from admission
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Bacteriuria
Tidsramme: within 4 hours from admission
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Binary outcome defined by the microbiologist on urine culture analysis
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within 4 hours from admission
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Etterforskere
- Studiestol: Christian Backer Mogensen, University Hospital of Southern Denmark
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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. Review.
- 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. Review.
- 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.
- Garau J, Baquero F, Pérez-Trallero E, Pérez JL, Martín-Sánchez AM, García-Rey C, Martín-Herrero JE, Dal-Ré 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.
- 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.
- 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.
- 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.
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
1. mars 2021
Primær fullføring (Faktiske)
28. februar 2022
Studiet fullført (Faktiske)
1. juni 2022
Datoer for studieregistrering
Først innsendt
23. november 2020
Først innsendt som oppfylte QC-kriteriene
22. desember 2020
Først lagt ut (Faktiske)
23. desember 2020
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
16. september 2022
Siste oppdatering sendt inn som oppfylte QC-kriteriene
15. september 2022
Sist bekreftet
1. september 2022
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- SHS-ED-11e-2020
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Nei
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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