Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01592799
First received: May 3, 2012
Last updated: NA
Last verified: May 2012
History: No changes posted
  Purpose

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.


Condition Intervention
Influenza
Procedure: Throat swab and/or nasopharyngeal swab
Other: Data collection

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: Burden of Influenza-related Hospitalizations and ER Visits in Children in Spain

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Laboratory-confirmed influenza in children presenting with ARI and/or isolated fever [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]
  • Direct medical cost per hospitalization or ER visit with laboratory-confirmed influenza [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Laboratory-confirmed respiratory viruses in children presenting with ARI and/or isolated fever [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]
  • Occurrence of death [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]
  • Occurrence of secondary bacterial infections [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]
  • Potential risk factors [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]
  • Number of days of hospitalization [ Time Frame: Day 0 till Day 28-37 (between October 2010 until May 2011) ] [ Designated as safety issue: No ]
  • Use of medication [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]
  • Number of days of school absenteeism [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]
  • Number of days of parent or caregiver time off work [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]
  • Number of household members with influenza-like illness [ Time Frame: Day 0 till Day 28-37 ] [ Designated as safety issue: No ]

Enrollment: 501
Study Start Date: November 2010
Study Completion Date: May 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.
Procedure: Throat swab and/or nasopharyngeal swab
Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.
Other: Data collection
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.

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.

  Eligibility

Ages Eligible for Study:   up to 15 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01592799

Locations
Spain
GSK Investigational Site
Bilbao, Spain, 48013
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01592799     History of Changes
Other Study ID Numbers: 114004
Study First Received: May 3, 2012
Last Updated: May 3, 2012
Health Authority: Spain: Ministry of Health

Keywords provided by GlaxoSmithKline:
Influenza
Children
Hospitalizations
Spain
Burden

Additional relevant MeSH terms:
Influenza, Human
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on July 31, 2014