Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 501
- 试验地点
- 2
- 主要终点
- Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Other
- 盲法
- None
入排标准
- 年龄范围
- — 至 15 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •ARI defined as one or more of the following symptoms: sore throat, coryza, cough, breathing difficulties.
排除标准
- •Children in foster care.
研究组 & 干预措施
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.
干预措施: Throat swab and/or nasopharyngeal swab (Procedure)
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.
干预措施: Data collection (Other)
结局指标
主要结局
Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
时间窗: 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.
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
时间窗: Day 0 till Day 28-37
Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
次要结局
- Number of Subjects With Other Laboratory-confirmed Respiratory Viruses(Day 0 till Day 28-37)
- Number of Subjects With Fatal Outcomes(Day 0 till Day 28-37)
- Number of Subjects With Secondary Bacterial Infections(Day 0 till Day 28-37)
- Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status(Day 0 till Day 28-37)
- Number of Days of Hospitalization(Day 0 till Day 28-37 (between October 2010 until May 2011))
- Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status(Day 0 till Day 28-37)
- Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status(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(Day 0 till Day 28-37)
- Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit(Day 0 till Day 28-37)
- Number of Days of School Absenteeism(Day 0 till Day 28-37)
- Number of Days of Parent or Caregiver Time Off Work(Day 0 till Day 28-37)
- Number of Subjects With Household Members With Influenza-like Illness(Day 0 till Day 28-37)
- Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)(Day 0 till Day 28-37)