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

GlaxoSmithKline501 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

OTHER

Masking

NONE

Enrollment

501

Conditions

Influenza

Interventions

Throat swab and/or nasopharyngeal swabPROCEDURE

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

Data collectionOTHER

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.

Eligibility

Sex: ALLMax age: 15 Years

Medical Language ↔ Plain English

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.

Locations (1)

GSK Investigational Site

Bilbao, Spain

Outcomes

Primary Outcomes

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

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.