Clinical Characteristics of Acutely Hospitalized Adults With Community-acquired- Pneumonia
2022年9月15日 更新者：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.
研究概览
详细说明
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
研究类型
观察性的
注册 (实际的)
966
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
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Aabenraa、丹麦
- Hospital of Southern Jutland
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参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
18年 及以上 (成人、年长者)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
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).
描述
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)
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 观测模型：队列
- 时间观点：横截面
队列和干预
团体/队列 |
干预/治疗 |
|---|---|
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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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研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Diagnosis of community acquired pneumonia
大体时间：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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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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Intensive care unit (ICU) treatment:
大体时间：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
大体时间：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天死亡率
大体时间：从入院到急诊科 30 天
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进入急诊室后 30 天内的死亡率
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从入院到急诊科 30 天
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再入院
大体时间：出院后30天内
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如果受试者在当前住院出院后 30 天内入院，则测量为二元结果重新入院/不重新入院。
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出院后30天内
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住院死亡率
大体时间：进入急诊科后 60 天内
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当前住院期间的患者死亡率。
二元结果 - 死亡/未死亡
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进入急诊科后 60 天内
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其他结果措施
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
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90 days mortality
大体时间：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
大体时间：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)
大体时间：: 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
大体时间：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
大体时间：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
大体时间：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
大体时间：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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合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
调查人员
- 学习椅：Christian Backer Mogensen、University Hospital of Southern Denmark
出版物和有用的链接
负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。
一般刊物
- 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.
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2021年3月1日
初级完成 (实际的)
2022年2月28日
研究完成 (实际的)
2022年6月1日
研究注册日期
首次提交
2020年11月23日
首先提交符合 QC 标准的
2020年12月22日
首次发布 (实际的)
2020年12月23日
研究记录更新
最后更新发布 (实际的)
2022年9月16日
上次提交的符合 QC 标准的更新
2022年9月15日
最后验证
2022年9月1日
更多信息
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