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
Clinicaltrials.gov ID
NCT01592799
See results summary
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

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
    Primary completion date:
    2011-23-05
    Observational study model:
    Not applicable
    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:

      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.

    Trial location(s)

    Location
    Status
    Contact us
    Contact us
    Location
    GSK Investigational Site
    Bilbao, Spain, 48013
    Status
    Study Complete
    Contact us

    Study documents

    No study documents available.

    Results overview

    Results posted on ClinicalTrials.gov

    Recruitment status
    Study complete
    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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