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

NCT01592799 | Completed Results

• 1 other identifier: 114004
• Study Type: interventional
• Target: 501
• Locations: 1 country
• Sites: 1

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.

Conditions

Influenza

Keywords

Influenza; Children; Hospitalizations; Spain; Burden

Outcome Measures

Primary Outcomes (2)

• 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.

  Day 0 till Day 28-37

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

  Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.

  Day 0 till Day 28-37

Secondary Outcomes (13)

• Number of Subjects With Other Laboratory-confirmed Respiratory Viruses

  Day 0 till Day 28-37

• Number of Subjects With Fatal Outcomes

  Day 0 till Day 28-37

• Number of Subjects With Secondary Bacterial Infections

  Day 0 till Day 28-37

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

  Day 0 till Day 28-37

• Number of Days of Hospitalization

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

Study Arms (1)

Influenza Group

OTHER

Children \<15 years of age hospitalized for or presenting to an ER for acute ARI and/or isolated fever during the influenza season.

Procedure: Throat swab and/or nasopharyngeal swab; Other: Data collection

Interventions

Throat swab and/or nasopharyngeal swab PROCEDURE

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

Influenza Group

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.

Influenza Group

Eligibility Criteria

• Age: Up to 15 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• Children in foster care.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Bilbao, 48013, Spain

Location

MeSH Terms

Conditions

Influenza, Human

Interventions

Data Collection

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Orthomyxoviridae Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases

Intervention Hierarchy (Ancestors)

Epidemiologic Methods; Investigative Techniques; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

866-435-7343

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 3, 2012
• First Posted: May 7, 2012
• Study Start: November 23, 2010
• Primary Completion: May 23, 2011
• Study Completion: May 23, 2011
• Last Updated: July 27, 2018
• Results First Posted: July 27, 2018

Record last verified: 2018-06

Locations

ES (1)