- ICH GCP
- Yhdysvaltain kliinisten tutkimusten rekisteri
- Kliininen tutkimus NCT04681963
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
Tutkimuksen yleiskatsaus
Tila
Ehdot
Interventio / Hoito
Yksityiskohtainen kuvaus
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
Opintotyyppi
Ilmoittautuminen (Todellinen)
Yhteystiedot ja paikat
Opiskelupaikat
-
-
-
Aabenraa, Tanska
- Hospital of Southern Jutland
-
-
Osallistumiskriteerit
Kelpoisuusvaatimukset
Opintokelpoiset iät
Hyväksyy terveitä vapaaehtoisia
Sukupuolet, jotka voivat opiskella
Näytteenottomenetelmä
Tutkimusväestö
Kuvaus
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)
Opintosuunnitelma
Miten tutkimus on suunniteltu?
Suunnittelun yksityiskohdat
- Havaintomallit: Kohortti
- Aikanäkymät: Poikkileikkaus
Kohortit ja interventiot
Ryhmä/Kohortti |
Interventio / Hoito |
---|---|
Suspected pneumonia diagnosis
Acutely admitted patients suspected having pneumonia.
|
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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Mitä tutkimuksessa mitataan?
Ensisijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Diagnosis of community acquired pneumonia
Aikaikkuna: 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. |
expert assessment within 3 months after patient discharge from the hospital
|
Toissijaiset tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
Intensive care unit (ICU) treatment:
Aikaikkuna: 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)
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within 60 days from admission to the emergency department
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Length of hospital stay
Aikaikkuna: 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
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within 60 days from current admission to the emergency department
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30 päivän kuolleisuus
Aikaikkuna: 30 päivää päivystykseen saapumisesta
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Kuolleisuus 30 päivän sisällä päivystykseen saapumisesta
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30 päivää päivystykseen saapumisesta
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Takaisinotto
Aikaikkuna: 30 päivän kuluessa sairaalaan saapumisesta
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Jos koehenkilö otetaan hoitoon 30 vuorokauden aikana nykyisen sairaalahoidon jälkeen mitattuna binäärituloksella Uusintaotto/ei uusintaotto.
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30 päivän kuluessa sairaalaan saapumisesta
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Sairaalakuolleisuus
Aikaikkuna: 60 päivän kuluessa päivystykseen saapumisesta
|
Potilaskuolleisuus nykyisen sairaalahoidon aikana.
Binääritulos - kuollut/ei kuollut
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60 päivän kuluessa päivystykseen saapumisesta
|
Muut tulostoimenpiteet
Tulosmittaus |
Toimenpiteen kuvaus |
Aikaikkuna |
---|---|---|
90 days mortality
Aikaikkuna: within 90 days from admission to emergency department
|
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
Aikaikkuna: 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)
Aikaikkuna: : 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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
Aikaikkuna: 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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Yhteistyökumppanit ja tutkijat
Sponsori
Tutkijat
- Opintojen puheenjohtaja: Christian Backer Mogensen, University Hospital of Southern Denmark
Julkaisuja ja hyödyllisiä linkkejä
Yleiset julkaisut
- 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.
Opintojen ennätyspäivät
Opi tärkeimmät päivämäärät
Opiskelun aloitus (Todellinen)
Ensisijainen valmistuminen (Todellinen)
Opintojen valmistuminen (Todellinen)
Opintoihin ilmoittautumispäivät
Ensimmäinen lähetetty
Ensimmäinen toimitettu, joka täytti QC-kriteerit
Ensimmäinen Lähetetty (Todellinen)
Tutkimustietojen päivitykset
Viimeisin päivitys julkaistu (Todellinen)
Viimeisin lähetetty päivitys, joka täytti QC-kriteerit
Viimeksi vahvistettu
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Avainsanat
Muita asiaankuuluvia MeSH-ehtoja
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