Back to resultsStudy on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain
Primary Purpose
Influenza
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
Throat swab and/or nasopharyngeal swab
Data collection
Sponsored by
About this trial
This is an interventional other trial for Influenza focused on measuring Influenza, Children, Hospitalizations, Spain, Burden
Eligibility Criteria
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.
Sites / Locations
- GSK Investigational Site
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
Influenza Group
Arm Description
Children <15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season.
Outcomes
Primary Outcome Measures
Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
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
Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
Secondary Outcome Measures
Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
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.
Number of Subjects With Fatal Outcomes
Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
Number of Subjects With Secondary Bacterial Infections
The outcome assessed the various complications by laboratory-confirmed influenza status.
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
Number of Days of Hospitalization
The outcomes was assessed in subjects with laboratory-confirmed influenza status
Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Number of Days of School Absenteeism
School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
Number of Days of Parent or Caregiver Time Off Work
This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.
Number of Subjects With Household Members With Influenza-like Illness
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.
Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01592799
Brief Title
Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain
Official Title
Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
November 23, 2010 (undefined)
Primary Completion Date
May 23, 2011 (Actual)
Study Completion Date
May 23, 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
GlaxoSmithKline
4. Oversight
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza
Keywords
Influenza, Children, Hospitalizations, Spain, Burden
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
501 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Influenza Group
Arm Type
Other
Arm Description
Children <15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season.
Intervention Type
Procedure
Intervention Name(s)
Throat swab and/or nasopharyngeal swab
Intervention Description
Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.
Intervention Type
Other
Intervention Name(s)
Data collection
Intervention Description
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.
Primary Outcome Measure Information:
Title
Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
Description
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.
Time Frame
Day 0 till Day 28-37
Title
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
Description
Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
Time Frame
Day 0 till Day 28-37
Secondary Outcome Measure Information:
Title
Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
Description
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.
Time Frame
Day 0 till Day 28-37
Title
Number of Subjects With Fatal Outcomes
Description
Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
Time Frame
Day 0 till Day 28-37
Title
Number of Subjects With Secondary Bacterial Infections
Description
The outcome assessed the various complications by laboratory-confirmed influenza status.
Time Frame
Day 0 till Day 28-37
Title
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
Description
Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
Time Frame
Day 0 till Day 28-37
Title
Number of Days of Hospitalization
Description
The outcomes was assessed in subjects with laboratory-confirmed influenza status
Time Frame
Day 0 till Day 28-37 (between October 2010 until May 2011)
Title
Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Description
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Time Frame
Day 0 till Day 28-37
Title
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Description
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Time Frame
Day 0 till Day 28-37
Title
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Description
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Time Frame
Day 0 till Day 28-37
Title
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit
Description
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Time Frame
Day 0 till Day 28-37
Title
Number of Days of School Absenteeism
Description
School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
Time Frame
Day 0 till Day 28-37
Title
Number of Days of Parent or Caregiver Time Off Work
Description
This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.
Time Frame
Day 0 till Day 28-37
Title
Number of Subjects With Household Members With Influenza-like Illness
Description
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.
Time Frame
Day 0 till Day 28-37
Title
Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
Description
This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.
Time Frame
Day 0 till Day 28-37
10. Eligibility
Sex
All
Maximum Age & Unit of Time
15 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Bilbao
ZIP/Postal Code
48013
Country
Spain
12. IPD Sharing Statement
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Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain
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