Last updated: 11/03/2018 15:59:23
Study on the Burden of influenza-related hospitalizations and emergency room (ER) visits in children in Spain
GSK study ID
114004
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: Burden of influenza-related hospitalizations and Emergency Room visits in children in Spain
Trial description: 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.
Primary purpose:
Other
Trial design:
Single Group Assignment
Masking:
None (Open Label)
Allocation:
Not applicable
Primary outcomes:
Number of subjects with laboratory-confirmed influenza presenting with an acute respiratory illness (ARI) and/or isolated fever
Timeframe: Day 0 till Day 28-37
Direct medical cost per hospitalization or ER visit with laboratory-confirmed influenza
Timeframe: Day 0 till Day 28-37
Secondary outcomes:
Number of subjects with other laboratory-confirmed respiratory viruses
Timeframe: Day 0 till Day 28-37
Number of subjects with fatal outcomes
Timeframe: Day 0 till Day 28-37
Number of subjects with secondary bacterial infections
Timeframe: Day 0 till Day 28-37
Number of subjects with potential risk factors at study start by laboratory-confirmed influenza status
Timeframe: Day 0 till Day 28-37
Number of days of hospitalization
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Day 0 till Day 28-37
Number of days of school Absenteeism
Timeframe: Day 0 till Day 28-37
Number of days of parent or caregiver time off work
Timeframe: Day 0 till Day 28-37
Number of subjects with household members with influenza-like illness
Timeframe: Day 0 till Day 28-37
Proportion of household members presenting influenza like illness symptoms (ARI and/or isolated fever)
Timeframe: Day 0 till Day 28-37
Interventions:
Procedure/surgery: Throat swab and/or nasopharyngeal swab
Other: Data collection
Enrollment:
501
Observational study model:
Not applicable
Primary completion date:
2011-23-05
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Influenza
Product
GSK2647158A
Collaborators
Not applicable
Study date(s)
November 2010 to May 2011
Type
Interventional
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable - 15 years
Accepts healthy volunteers
No
- 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.
- Children in foster care.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
Subjects for whom the investigator believes that they and/or their parents/guardians can and will comply with the requirements of the protocol.
Exclusion criteria:
Children in foster care.
Trial location(s)
Study documents
No study documents available.
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2011-23-05
Actual study completion date
2011-23-05
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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