Managing Bacterial Pneumonia in Children Without Antimicrobials
Can Community-acquired Bacterial Pneumonia in Children be Safely Managed Without Antibiotics in an Integrative Medicine Context? A Retrospective Cohort Analysis
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.
研究概览
详细说明
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.
研究类型
观察性的
注册 (实际的)
350
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习地点
-
-
Baden-Württemberg
-
Filderstadt、Baden-Württemberg、德国、70794
- Arcim Institute
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
不超过 18年 (孩子、成人)
接受健康志愿者
不
有资格学习的性别
全部
取样方法
概率样本
研究人群
Children from infancy till adolecence admitted to hospital (Filderklinik, Germany) for pneumonia treatment
描述
Inclusion Criteria:
- 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)
Exclusion Criteria:
- None
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Cure rate of non-antimicrobial management of bacterial pneumonia
大体时间：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.
|
Between admission and 3 months after discharge
|
|
Medical complication rate
大体时间：Between admission and 3 months after discharge
|
Medical complication rate among children with bacterial pneumonia, treated with or without antimicrobials
|
Between admission and 3 months after discharge
|
|
Length of hospital stay
大体时间：Between admission and 3 months after discharge
|
Length of hospital stay for children with bacterial pneumonia, managed with or without antimicrobials
|
Between admission and 3 months after discharge
|
|
Readmission rate
大体时间：7 - 10 years after hospitalization
|
Readmission rate for pneumonia among children with bacterial pneumonia, managed with or without antimicrobials
|
7 - 10 years after hospitalization
|
|
Temperature normalization
大体时间：Between admission and 3 months after discharge
|
Days to temperature normalization (< 38°C) in children with bacterial pneumonia, managed with or without antimicrobials
|
Between admission and 3 months after discharge
|
|
Days of supplemental oxygen need
大体时间：Between admission and 3 months after discharge
|
Days of supplemental oxygen need in children with bacterial pneumonia, managed with or without antimicrobials
|
Between admission and 3 months after discharge
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Changes in respiratory rate
大体时间：Between admission and 3 months after discharge
|
Changes in respiratory rate as an indicator for pulmonary infection
|
Between admission and 3 months after discharge
|
|
Changes in Bacterial Pneumonia Score
大体时间：Between admission and 3 months after discharge
|
Changes in Bacterial Pneumonia Score as an indicator for pulmonary infection
|
Between admission and 3 months after discharge
|
|
Changes in oxygen saturation
大体时间：Between admission and 3 months after discharge
|
Changes in oxygen saturation as an indicator for pulmonary infection
|
Between admission and 3 months after discharge
|
|
Changes in CRP
大体时间：Between admission and 3 months after discharge
|
Changes in CRP as an indicator for infection
|
Between admission and 3 months after discharge
|
|
Changes in leukocyte count
大体时间：Between admission and 3 months after discharge
|
Changes in leukocyte count as an indicator for infection
|
Between admission and 3 months after discharge
|
|
Changes in pH
大体时间：Between admission and 3 months after discharge
|
Changes in pH as an indicator for respiratory distress
|
Between admission and 3 months after discharge
|
|
Changes in pCO2
大体时间：Between admission and 3 months after discharge
|
Changes in pCO2 as an indicator for respiratory distress
|
Between admission and 3 months after discharge
|
|
Rate of chronic and acute-infectious co-morbidities
大体时间：Day of admission
|
Rate of chronic and acute-infectious co-morbidities on admission in children with bacterial pneumonia, subsequently managed with or without antimicrobials
|
Day of admission
|
|
Utilization rate of a package of complementary treatment measures
大体时间：Between admission and 3 months after discharge
|
Utilization rate of a package of complementary treatment measures from anthroposophic medicine (including oral medications, inhalation and external nursing applications) in children managed with or without antimicrobials
|
Between admission and 3 months after discharge
|
|
Antimicrobial treatment rate in children with viral pneumonia
大体时间：Between admission and 3 months after discharge
|
Antimicrobial treatment rate in children classified as viral pneumonia by Bacterial Pneumonia Score
|
Between admission and 3 months after discharge
|
|
Number of patients treated with antipyretics
大体时间：Between admission and 3 months after discharge
|
Number of patients treated with antipyretics
|
Between admission and 3 months after discharge
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (实际的)
2017年10月15日
初级完成 (实际的)
2017年11月30日
研究完成 (实际的)
2018年2月25日
研究注册日期
首次提交
2017年7月6日
首先提交符合 QC 标准的
2017年8月17日
首次发布 (实际的)
2017年8月22日
研究记录更新
最后更新发布 (实际的)
2020年2月17日
上次提交的符合 QC 标准的更新
2020年2月13日
最后验证
2020年2月1日
更多信息
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.
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