- ICH GCP
- Registro de ensayos clínicos de EE. UU.
- Ensayo clínico 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
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Descripción detallada
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
Tipo de estudio
Inscripción (Actual)
Contactos y Ubicaciones
Ubicaciones de estudio
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Aabenraa, Dinamarca
- Hospital of Southern Jutland
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Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Método de muestreo
Población de estudio
Descripción
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)
Plan de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Modelos observacionales: Grupo
- Perspectivas temporales: Transversal
Cohortes e Intervenciones
Grupo / Cohorte |
Intervención / Tratamiento |
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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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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Diagnosis of community acquired pneumonia
Periodo de tiempo: 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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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
---|---|---|
Intensive care unit (ICU) treatment:
Periodo de tiempo: 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
Periodo de tiempo: 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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Mortalidad a los 30 días
Periodo de tiempo: 30 días desde el ingreso a urgencias
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Mortalidad dentro de los 30 días desde el ingreso al Departamento de Emergencia
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30 días desde el ingreso a urgencias
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Readmisión
Periodo de tiempo: dentro de los 30 días desde el alta al hospital
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Si un sujeto es admitido durante un período de 30 días después del alta hospitalaria actual medido como un resultado binario Reingresos/no reingresos.
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dentro de los 30 días desde el alta al hospital
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Mortalidad intrahospitalaria
Periodo de tiempo: dentro de los 60 días desde la admisión al servicio de urgencias
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Mortalidad del paciente durante la hospitalización actual.
Resultado binario - Murió/ No murió
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dentro de los 60 días desde la admisión al servicio de urgencias
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Otras medidas de resultado
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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90 days mortality
Periodo de tiempo: 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
Periodo de tiempo: 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)
Periodo de tiempo: : 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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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Colaboradores e Investigadores
Patrocinador
Investigadores
- Silla de estudio: Christian Backer Mogensen, University Hospital of Southern Denmark
Publicaciones y enlaces útiles
Publicaciones Generales
- 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.
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio (Actual)
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Actual)
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- SHS-ED-11e-2020
Plan de datos de participantes individuales (IPD)
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Información sobre medicamentos y dispositivos, documentos del estudio
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