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

Influenza Clinical Trial

Official title:

Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01592799
• Other study ID #: 114004
• Status: Completed
• Phase: N/A
• Start date: November 23, 2010
• Est. completion date: May 23, 2011

Study information

• Verified date: June 2018
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 501
• Est. completion date: May 23, 2011
• Est. primary completion date: May 23, 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 15 Years

Eligibility

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.

Related Conditions & MeSH terms

• Emergencies
• Influenza
• Influenza, Human

Intervention

Procedure:
• Throat swab and/or nasopharyngeal swab
Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.

Other:
• 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.

Locations

Country	Name	City	State
Spain	GSK Investigational Site	Bilbao

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Number of Subjects With Other Laboratory-confirmed Respiratory Viruses	Among the other laboratory-confirmed respiratory viruses there were:adenovirus, respiratory syncytial virus, parainfluenza virus 1, 2 and 3, metapneumovirus, bocavirus, rhinovirus or coronavirus. The outcome was assessed in subjects with an acute respiratory illness (ARI) and/or isolated fever episode.	Day 0 till Day 28-37
Secondary	Number of Subjects With Fatal Outcomes	Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.	Day 0 till Day 28-37
Secondary	Number of Subjects With Secondary Bacterial Infections	The outcome assessed the various complications by laboratory-confirmed influenza status.	Day 0 till Day 28-37
Secondary	Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status	Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.	Day 0 till Day 28-37
Secondary	Number of Days of Hospitalization	The outcomes was assessed in subjects with laboratory-confirmed influenza status	Day 0 till Day 28-37 (between October 2010 until May 2011)
Secondary	Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status	ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.	Day 0 till Day 28-37
Secondary	Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status	ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.	Day 0 till Day 28-37
Secondary	Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status	ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.	Day 0 till Day 28-37
Secondary	Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit	ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.	Day 0 till Day 28-37
Secondary	Number of Days of School Absenteeism	School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.	Day 0 till Day 28-37
Secondary	Number of Days of Parent or Caregiver Time Off Work	This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.	Day 0 till Day 28-37
Secondary	Number of Subjects With Household Members With Influenza-like Illness	This outcome assessed the number of cases with household contacts presenting influenza like illness symptoms during the follow-up period by laboratory-confirmed influenza status.	Day 0 till Day 28-37
Secondary	Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)	This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.	Day 0 till Day 28-37