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临床试验/NCT02489578
NCT02489578Unknown不适用

Management in Real-life of Patients Hospitalized With Community-acquired Pneumonia in China

Capital Medical University1 个研究点 分布在 1 个国家目标入组 3,000 人开始时间: 2015年7月最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
3,000
试验地点
1
主要终点
treatment failure at 72h after initiation of antibiotics

研究概览

简要总结

The purpose of this study is to evaluate the disease burden of hospitalized patients with CAP and healthcare-associated pneumonia (HCAP) in real life of China .

详细描述

In China, the data about current management of patients hospitalized with CAP in the real-life setting is not available,type of pneumonia, selection of initial antibiotic, time to clinical stability, antibiotic choice anf modification,clinical outcomes and costs remain unclear.

In this study, we will collect comprehensive information on CAP and HCAP management patterns to evaluate the disease burden of hospitalized patients with CAP and HCAP in real life of China .to analyze microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of patients with CAP (> and = 65 years, different comorbidities ,risk factors) ,to investigate microbiological characteristics,clinical manifestations,antibiotic regimens ,adherences to guidelines and effect on outcome in different groups of disease severity with CAP ,to provide the difference on microbiological characteristics,clinical manifestations,antibiotic regimens ,and outcome between patients with CAP and HCAP ,to understand the current situation of antibiotic regimen ,to evaluate influence of different antibiotic regimens on prognosis.

研究设计

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

入排标准

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

入选标准

  • Patients > or = 14 years of age
  • Patient meets the criteria of community acquired pneumonia
  • Patient meets the criteria of healthcare-associated pneumonia

排除标准

  • Patients <14 years of age
  • Patient meets the criteria of hospital acquired pneumonia
  • Known active tuberculosis or current treatment for tuberculosis
  • Non-infectious pulmonary diseases
  • HIV positive

结局指标

主要结局

treatment failure at 72h after initiation of antibiotics

时间窗: Time from the first dose use of antibiotics to 72 hours

treatment failure was defined as a change of antibiotics due to worsening signs or symptoms associated with pneumonia

in-hospital treatment failure due to multiple causes

时间窗: Time from date of admission to discharge up to 1 week

1)death in hospital;2)change of antibiotics due to worsening signs or symptoms of infection, 3) recurrence, defined as signs or symptoms of infection after completion of therapy requiring re-initiation of antibiotics

次要结局

  • in-hospital mortality(2 weeks)
  • Duration of intravenous antimicrobial therapy(2 weeks)
  • Hospital length of stay(2 weeks)

研究者

发起方
Capital Medical University
申办方类型
Other
责任方
Principal Investigator
主要研究者

Bin Cao

MD

Capital Medical University

研究点 (1)

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