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临床试验/NCT02523885
NCT02523885已完成不适用

Descriptive Analysis of Non Steroidal Antiinflammatory Drugs Use in Patients Diagnosed With Community Acquired Pneumonia

Hôpital Louis Mourier4 个研究点 分布在 1 个国家目标入组 181 人开始时间: 2013年11月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
181
试验地点
4
主要终点
binary composite primary endpoint

研究概览

简要总结

To investigate exposure to nonsteroidal antiinflammatory drugs (NSAIDs) during outpatient management at the early stage of community-acquired pneumonia (CAP) requiring hospital consultation. Non-interventional observational study.

详细描述

Recent data suggests that such exposure to NSAIDs is associated with delay in CAP diagnosis and antibiotic prescription that influence CAP presention and outcome. The investigators' working hypothesis is that NSAIDs use may mask initial symptoms and delay antimicrobial therapy, thus predisposing to worse outcomes. All patients presenting at one of the three following locations (emergency department, ICU or pneumology ward) with a suspicion of community-acquired pneumonia will be screened for eligibility. Exposure or not to NSAIDs will be investigated. Clinical, biological and radioloigcal features and outcome of CAP will be compared with respect to NSAIDs exposure.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
18 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • at least two among the following signs
  • temperature > 37.8 °C
  • respiratory rate > 25/min
  • heat rate > 100/min
  • expectoration
  • chest pain
  • crackles upon lung auscultation
  • and new infiltrate on the chest x-ray

排除标准

  • ongoing pregnancy
  • sickle cell disease
  • tracheostomy
  • long term oxygen therapy
  • cystic fibrosis or bronchiectasis
  • neutropenia (< 500 cells/mm3)
  • ongoing solid or hematologic cancer or anticancerous chemotherapy
  • HIV infection
  • liver cirrhosis
  • long term corticosteroid treatment (20mg per day equivalent prednisone for more than 15 days)
  • preexisting treatment with NSAIDs for more than 15 days
  • hospital admission for more than 48hours
  • aspiration pneumonia

结局指标

主要结局

binary composite primary endpoint

时间窗: 28 days

presence or absence of one or more of the following : occurrence of at least one pneumonia-related complication; need for ICU admission; prolonged length of hospital stay. pneumonia-related complications include: worsening of hypoxemia; need for mechanical ventilation; occurrence or increase of pleural effusion; empyema; occurrence of septic shock;

次要结局

  • 28-day mortality(28 days)
  • CURB score at inclusion(2 days)
  • pneumonia severity index(2 days)
  • occurence of a nosocomial infection(28 days)
  • duration of antimicrobial therapy(28 days)

研究者

发起方
Hôpital Louis Mourier
申办方类型
Other
责任方
Principal Investigator
主要研究者

Prof Jean-Damien RICARD

Professor of Intensive Care Medicine, assistant head of ICU

Hôpital Louis Mourier

研究点 (4)

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