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临床试验/NCT01336036
NCT01336036已完成不适用

Etiology, Clinical Manifestations and Risk Factors for Community-acquired Pneumonia in Patients Admitted to Hospital

Oxford University Clinical Research Unit, Vietnam2 个研究点 分布在 1 个国家目标入组 300 人开始时间: 2011年2月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
300
试验地点
2
主要终点
Proportion of patients who are stable at Day 3, 7 and 14

研究概览

简要总结

This is a descriptive clinical research aiming:

  • To describe the clinical spectrum and clinical characteristics of community acquired pneumonia (CAP) in patients admitted to hospital
  • To identify the etiology of CAP and the antibiotic sensitivity of the isolated organisms
  • To identify the risk factors that influence the severity of CAP

详细描述

In Vietnam, the range and relative contribution of organisms causing CAP remain unclear, largely because diagnostic tools are limited and clinical research uncommon. An improved understanding of the risk factors, etiology and clinical outcomes of CAP in Vietnam would contribute to improved approaches to patient diagnosis and clinical management. This will be achieved by following the clinical and laboratory progress and treatment outcomes of in-patients diagnosed with CAP from admission to discharge. Comparative analyses will be between subgroups including survivor and non-survivor, severe CAP and non-severe CAP, known etiology and unknown etiology, SIRS, sepsis, severe sepsis and shock septic.

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 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Patients > or = 18 years of age
  • Patient meets the criteria of pneumonia (below), established within 36h of hospitalization
  • Patient is not hospitalized or residing in a long-term-care facility within 14 days before the onset of symptoms
  • Patient has not been at a referral hospital for >2 days before admission to the study hospital
  • Informed consent to participate in the study is provided

排除标准

  • Severe immunosuppression as judged by the enrolling physician (e.g. HIV, leukemia, lymphoma, chemotherapy for solid tumors, long-term corticosteroid use or other immunosuppressive drugs)
  • Known active tuberculosis or current treatment for tuberculosis

结局指标

主要结局

Proportion of patients who are stable at Day 3, 7 and 14

时间窗: up to 14 days

• Criteria for clinical stability * Temperature \< or = 37.8oC * Heart rate \< or = 100 beats/min * Respiratory rate \< or = 24 breaths/min * Systolic blood pressure \> or = 90 mm Hg * Arterial oxygen saturation \> or = 90% or pO2 \> or = 60 mm Hg on room air * Ability to maintain oral intake * Normal mental status

次要结局

  • Need for mechanical ventilation(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
  • Length of ventilation time(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)
  • Day 14 mortality(14 days)
  • Length of stay (days)(participants will be followed for the duration of hospital stay, an expected average of 2 weeks)

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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