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Completed

NCT Number: NCT01592799

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

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.

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Key information

Conditions

Influenza Infections Influenza, Human Orthomyxoviridae Infections RNA Virus Infections Respiratory Tract Diseases Respiratory Tract Infections Virus Diseases

Age range

Up to 15 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Bilbao, 48013, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Throat swab and/or nasopharyngeal swab

Procedure

Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.

Data Collection

Other

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 outcomes

  1. Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever

    Time frame: 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.

  2. Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza

    Time frame: 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.

Secondary outcomes

  1. Number of Subjects With Other Laboratory-confirmed Respiratory Viruses

    Time frame: Day 0 till Day 28-37

    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.

  2. Number of Subjects With Fatal Outcomes

    Time frame: Day 0 till Day 28-37

    Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.

  3. Number of Subjects With Secondary Bacterial Infections

    Time frame: Day 0 till Day 28-37

    The outcome assessed the various complications by laboratory-confirmed influenza status.

  4. Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status

    Time frame: Day 0 till Day 28-37

    Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.

  5. Number of Days of Hospitalization

    Time frame: Day 0 till Day 28-37 (between October 2010 until May 2011)

    The outcomes was assessed in subjects with laboratory-confirmed influenza status

  6. Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

    Time frame: Day 0 till Day 28-37

    ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

  7. Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

    Time frame: Day 0 till Day 28-37

    ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

  8. Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status

    Time frame: Day 0 till Day 28-37

    ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

  9. Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit

    Time frame: Day 0 till Day 28-37

    ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

  10. Number of Days of School Absenteeism

    Time frame: Day 0 till Day 28-37

    School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.

  11. Number of Days of Parent or Caregiver Time Off Work

    Time frame: Day 0 till Day 28-37

    This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.

  12. Number of Subjects With Household Members With Influenza-like Illness

    Time frame: Day 0 till Day 28-37

    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.

  13. Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)

    Time frame: Day 0 till Day 28-37

    This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
May 7, 2012
Registry last updated
Jul 27, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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