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

NCT ID: NCT01592799

Last Updated: 2018-07-27

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 501 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-11-23
• Study Completion Date: 2011-05-23

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.

Conditions

Influenza

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Throat swab and/or nasopharyngeal swab

Intervention Type: PROCEDURE

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

Data collection

Intervention Type: 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.

Interventions

Throat swab and/or nasopharyngeal swab

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

Intervention Type: PROCEDURE

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.

Intervention Type: OTHER

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.

• Maximum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

GSK Investigational Site

Bilbao, , Spain

Countries

Spain

Other Identifiers

114004

Identifier Type: -

Identifier Source: org_study_id