Clinical trial NCT01592799: 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
Overall status: COMPLETED
Phase: NA
Conditions: Influenza
Keywords: Influenza
Children
Hospitalizations
Spain
Burden
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-05-07
Enrollment: 501
Sex: ALL
Maximum age (years): 15
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: OTHER

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.

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.

Primary outcomes:
measure: 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
measure: Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
timeFrame: Day 0 till Day 28-37
Secondary outcomes:
measure: Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
timeFrame: Day 0 till Day 28-37
measure: Number of Subjects With Fatal Outcomes
timeFrame: Day 0 till Day 28-37
measure: Number of Subjects With Secondary Bacterial Infections
timeFrame: Day 0 till Day 28-37
measure: Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
timeFrame: Day 0 till Day 28-37
measure: Number of Days of Hospitalization
timeFrame: Day 0 till Day 28-37 (between October 2010 until May 2011)
measure: 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
measure: 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
measure: 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
measure: 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
measure: Number of Days of School Absenteeism
timeFrame: Day 0 till Day 28-37
measure: Number of Days of Parent or Caregiver Time Off Work
timeFrame: Day 0 till Day 28-37
measure: Number of Subjects With Household Members With Influenza-like Illness
timeFrame: Day 0 till Day 28-37
measure: Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
timeFrame: Day 0 till Day 28-37
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: