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临床试验/NCT01574066
NCT01574066已完成不适用

Chest CT-scan for the Diagnosis of Community-acquired Pneumonia in Patients Visiting the Emergency Department

Assistance Publique - Hôpitaux de Paris8 个研究点 分布在 1 个国家目标入组 339 人开始时间: 2011年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
339
试验地点
8
主要终点
Chest CT-scan

研究概览

简要总结

Primary objective : to estimate impact of CT-scan on diagnostic for emergency department (ED) patients with suspected Community-acquired Pneumonia (CAP).

Secondary objective: to estimate impact of CT-scan on treatment (antimicrobial therapy) and site of care for ED patients with suspected CAP.

详细描述

Rational: Community-acquired pneumonia (CAP) is a frequent infectious disorder in patients visiting the ED. CAP is responsible for high morbidity and associated-mortality is increasing in Western countries. CAP corresponds to invasion of the lung by pathogens. Diagnosis depends on clinical and X-ray assessment. However, these signs and symptoms are poorly specific and are often lacking. As prognosis depends on precocious and fitted antimicrobial treatment, making CAP diagnosis in a short time span (4-8 hours) is mandatory. Preliminary studies suggest that chest CT-scan could over-performed X-ray for diagnosis of CAP. Consensus conferences suggest the use of CT-scan in patients with uncertain diagnosis and unusual presentation and outcome. Because CT-scan is currently easily available, its use in a first intent is questionable for ED patients with suspected CAP.

Primary objective: to estimate impact of CT-scan on diagnostic for ED patients with suspected CAP.

Secondary objective: to estimate impact of CT-scan on treatment (antimicrobial therapy) and site of care for ED patients with suspected CAP.

Prospective multicenter study to measure chest CT-scan impact. 350 patients visiting the ED of 4 inner tertiary teaching hospitals in Paris, France, with suspected CAP.

Management: Patients will be managed according to current guidelines, including conventional chest X-ray.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patient above 18 years of age
  • Patient with a presumptive diagnosis of CAP according to attending ED physician
  • Patient experiencing at least one systemic sign (T°>38°C or < 36°C, HR>90/min, RR>20/min)
  • Patient experiencing one respiratory sign (cough, lateral chest pain, localized crackles, dyspnea) that recently appeared
  • Patient with a prior medical examination, the results have been or will be communicated
  • Patient gave written informed consent or in cases of emergency parent/ support person who gave written informed consent if he/she is present on the day of inclusion

排除标准

  • Pregnancy
  • Patient with shock
  • Patient with respiratory distress and immune suppression
  • Patient with other criteria for immediate ICU referral to ICU
  • Patient with living conditions making it impossible to follow 28 days
  • Patient not affiliated with a social security system

结局指标

主要结局

Chest CT-scan

时间窗: in 28 days

Percentage of diagnoses modified by chest CT-scan.

次要结局

  • Treatments changes(in 28 days)
  • Changes of site-of-care(in 28 days)
  • Identification of viral and bacterial agents(at day of inclusion (day 1))
  • Markers of infection in the blood(at day of inclusion (day 1))
  • Markers of infection and markers of inflammation in urine(at day of inclusion (day 1))

研究者

申办方类型
Other
责任方
Sponsor

研究点 (8)

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