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

GlaxoSmithKline (GSK)

Status

Completed

Conditions

Influenza

Treatments

Procedure: Throat swab and/or nasopharyngeal swab

Other: Data collection

Study type

Interventional

Funder types

Industry

Identifiers

NCT01592799

114004

Details and patient eligibility

About

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.

Full 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.

Enrollment

501 patients

Sex

All

Ages

Under 15 years old

Volunteers

No Healthy Volunteers

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