Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain
2018年6月12日 更新者：GlaxoSmithKline
Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain
This study aims to quantify the inpatient and ER visits burden of laboratory-confirmed influenza, and compare the clinical features, severity, complications, risk factors and socioeconomic impact of influenza in children presenting with acute respiratory illness (ARI) and/or isolated fever, with or without laboratory-confirmed influenza.
研究概览
详细说明
The total medical cost associated with each hospitalization or ER visit will also be calculated at the end of this study.
The study will be conducted from October, 2010, until May, 2011. Each subject will be followed-up for 21-30 days via telephone. The follow-up medical chart review will preferably be performed within 7 days after the telephone contact.
研究类型
介入性
注册 (实际的)
501
阶段
- 不适用
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
-
-
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Bilbao、西班牙、48013
- GSK Investigational Site
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-
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 15年 (孩子)
接受健康志愿者
不
有资格学习的性别
全部
描述
Inclusion Criteria:
- Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
- A male or female <15 years of age at the time of study entry. A subject will become ineligible on his/her 15th birthday.
- Signed informed consent from the parents or guardians of the subject and signed assent from children ≥ 12 years old.
Presenting with a sudden onset clinical process comprising :
- Isolated fever defined as: oral temperature ≥ 37.5°C / axillary temperature ≥ 37.5°C / Rectal temperature ≥ 38°C / tympanic temperature on oral setting ≥ 37.5°C / tympanic temperature on rectal setting ≥ 38°C without an obvious cause.
And/or
- ARI defined as one or more of the following symptoms: sore throat, coryza, cough, breathing difficulties.
Exclusion Criteria:
• Children in foster care.
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
- 主要用途：其他
- 分配：不适用
- 介入模型：单组作业
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
其他：Influenza Group
Children <15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season.
|
Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.
Log Sheet will be used to collected data on a monthly basis for the following age groups: < 6 months; 6-23 months; 24-59 months; > 5 years.
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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 |
|---|---|---|
|
Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
大体时间：Day 0 till Day 28-37
|
ARI was defined as one or more of the following symptoms: sore throat (in children greater than or equal to (≥) 3 years old), coryza (runny nose), cough, breathing difficulties.
Isolated fever was defined as: oral temperature ≥37.5°C / axillary temperature ≥37.5°C / Rectal temperature ≥38°C / tympanic temperature on oral setting ≥37.5°C / tympanic temperature on rectal setting ≥38°C without an obvious cause.
|
Day 0 till Day 28-37
|
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Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
大体时间：Day 0 till Day 28-37
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Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
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Day 0 till Day 28-37
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次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
大体时间：Day 0 till Day 28-37
|
Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus.
The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.
|
Day 0 till Day 28-37
|
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Number of Subjects With Fatal Outcomes
大体时间：Day 0 till Day 28-37
|
Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
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Day 0 till Day 28-37
|
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Number of Subjects With Secondary Bacterial Infections
大体时间：Day 0 till Day 28-37
|
The outcome assessed the various complications by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
|
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Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
大体时间：Day 0 till Day 28-37
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Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
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Day 0 till Day 28-37
|
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Number of Days of Hospitalization
大体时间：Day 0 till Day 28-37 (between October 2010 until May 2011)
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The outcomes was assessed in subjects with laboratory-confirmed influenza status
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Day 0 till Day 28-37 (between October 2010 until May 2011)
|
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Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
大体时间：Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
|
Day 0 till Day 28-37
|
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Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
大体时间：Day 0 till Day 28-37
|
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
|
Day 0 till Day 28-37
|
|
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
大体时间：Day 0 till Day 28-37
|
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
|
Day 0 till Day 28-37
|
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Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit
大体时间：Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
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Day 0 till Day 28-37
|
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Number of Days of School Absenteeism
大体时间：Day 0 till Day 28-37
|
School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
|
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Number of Days of Parent or Caregiver Time Off Work
大体时间：Day 0 till Day 28-37
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This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.
|
Day 0 till Day 28-37
|
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Number of Subjects With Household Members With Influenza-like Illness
大体时间：Day 0 till Day 28-37
|
This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
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Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
大体时间：Day 0 till Day 28-37
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This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.
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Day 0 till Day 28-37
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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
2010年11月23日
初级完成 (实际的)
2011年5月23日
研究完成 (实际的)
2011年5月23日
研究注册日期
首次提交
2012年5月3日
首先提交符合 QC 标准的
2012年5月3日
首次发布 (估计)
2012年5月7日
研究记录更新
最后更新发布 (实际的)
2018年7月27日
上次提交的符合 QC 标准的更新
2018年6月12日
最后验证
2018年6月1日
更多信息
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