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临床试验/NCT03256474
NCT03256474已完成不适用

Can Community-acquired Bacterial Pneumonia in Children be Safely Managed Without Antibiotics in an Integrative Medicine Context? A Retrospective Cohort Analysis

ARCIM Institute Academic Research in Complementary and Integrative Medicine1 个研究点 分布在 1 个国家目标入组 350 人开始时间: 2017年10月15日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
350
试验地点
1
主要终点
Readmission rate

研究概览

简要总结

Retrospective cohort analysis of children hospitalized for pneumonia comparing disease severity on admission, clinical course, treatment and outcomes and prospective telephone based Follow-Up assessement.

详细描述

The investigators will conduct a retrospective cohort analysis of children hospitalized for pneumonia at the Filderklinik between December 2006 and November 2010. The Bacterial Pneumonia Score, a validated composite laboratory, clinical and radiologic score developed by Moreno et al, will be retrospectively applied to define cases as either viral or bacterial pneumonia. The investigators will compare disease severity on admission, clinical course, and outcomes (in terms of complications, length of stay and readmission rates) between antimicrobial and non-antimicrobial managed bacterial pneumonia cases. Long-term Follow-Up will be assessed by telephone interviews with the parents.

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
— 至 18 Years(Child, Adult)
性别
All
接受健康志愿者

入选标准

  • Hospital admission at the pediatric department of the Filderklinik.
  • Admission diagnosis pneumonia (ICD J12.0, J12.1, J12.8, J12.9, J14, J15.1, J15.6, J15.7, J15.8, J15.9, J16.8, J18.0, J18.1, J18.8, J18.9 - all 12s, 15s, 16s, 18s)

排除标准

  • 未提供

结局指标

主要结局

Readmission rate

时间窗: 7 - 10 years after hospitalization

Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials

Days of supplemental oxygen need

时间窗: Between admission and 3 months after discharge

Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials

Medical complication rate

时间窗: Between admission and 3 months after discharge

Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials

Temperature normalization

时间窗: Between admission and 3 months after discharge

Days to temperature normalization (\< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials

Cure rate of non-antimicrobial management of bacterial pneumonia

时间窗: Between admission and 3 months after discharge

Cure rate of non-antimicrobial management of bacterial pneumonia (in the following and in the final publication, the term "bacterial pneumonia" will be used for children who fulfill the Moreno criteria for pneumonia): % of children managed without antimicrobials since admission, without subsequent need for antimicrobials or readmission.

Length of hospital stay

时间窗: Between admission and 3 months after discharge

Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials

次要结局

  • Changes in oxygen saturation(Between admission and 3 months after discharge)
  • Rate of chronic and acute-infectious co-morbidities(Day of admission)
  • Number of patients treated with antipyretics(Between admission and 3 months after discharge)
  • Changes in respiratory rate(Between admission and 3 months after discharge)
  • Changes in pH(Between admission and 3 months after discharge)
  • Changes in Bacterial Pneumonia Score(Between admission and 3 months after discharge)
  • Utilization rate of a package of complementary treatment measures(Between admission and 3 months after discharge)
  • Changes in CRP(Between admission and 3 months after discharge)
  • Changes in leukocyte count(Between admission and 3 months after discharge)
  • Changes in pCO2(Between admission and 3 months after discharge)
  • Antimicrobial treatment rate in children with viral pneumonia(Between admission and 3 months after discharge)

研究者

发起方
ARCIM Institute Academic Research in Complementary and Integrative Medicine
申办方类型
Other
责任方
Sponsor

研究点 (1)

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