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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01592799
Recruitment Status : Completed
First Posted : May 7, 2012
Results First Posted : July 27, 2018
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
GlaxoSmithKline

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.

Condition or disease Intervention/treatment Phase
Influenza Procedure: Throat swab and/or nasopharyngeal swab Other: Data collection Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 501 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain
Study Start Date : November 23, 2010
Actual Primary Completion Date : May 23, 2011
Actual Study Completion Date : May 23, 2011

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Fever Flu Flu Shot

Arm Intervention/treatment
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.
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.




Primary Outcome Measures :
  1. Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever [ Time Frame: Day 0 till Day 28-37 ]
    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.

  2. Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza [ Time Frame: Day 0 till Day 28-37 ]
    Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.


Secondary Outcome Measures :
  1. Number of Subjects With Other Laboratory-confirmed Respiratory Viruses [ Time Frame: Day 0 till Day 28-37 ]
    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.

  2. Number of Subjects With Fatal Outcomes [ Time Frame: Day 0 till Day 28-37 ]
    Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.

  3. Number of Subjects With Secondary Bacterial Infections [ Time Frame: Day 0 till Day 28-37 ]
    The outcome assessed the various complications by laboratory-confirmed influenza status.

  4. Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status [ Time Frame: Day 0 till Day 28-37 ]
    Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.

  5. Number of Days of Hospitalization [ Time Frame: Day 0 till Day 28-37 (between October 2010 until May 2011) ]
    The outcomes was assessed in subjects with laboratory-confirmed influenza status

  6. Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status [ Time Frame: Day 0 till Day 28-37 ]
    ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

  7. Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status [ Time Frame: Day 0 till Day 28-37 ]
    ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

  8. Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status [ Time Frame: Day 0 till Day 28-37 ]
    ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

  9. Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit [ Time Frame: Day 0 till Day 28-37 ]
    ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.

  10. Number of Days of School Absenteeism [ Time Frame: Day 0 till Day 28-37 ]
    School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.

  11. Number of Days of Parent or Caregiver Time Off Work [ Time Frame: Day 0 till Day 28-37 ]
    This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.

  12. Number of Subjects With Household Members With Influenza-like Illness [ Time Frame: Day 0 till Day 28-37 ]
    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.

  13. Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever) [ Time Frame: Day 0 till Day 28-37 ]
    This outcome assessed the proportion of influenza like illness (ILI) among household members of children < 15 years with and without laboratory-confirmed influenza.



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Ages Eligible for Study:   up to 15 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01592799


Locations
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Spain
GSK Investigational Site
Bilbao, Spain, 48013
Sponsors and Collaborators
GlaxoSmithKline
Investigators
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Study Director: GSK Clinical Trials GlaxoSmithKline
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Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01592799    
Other Study ID Numbers: 114004
First Posted: May 7, 2012    Key Record Dates
Results First Posted: July 27, 2018
Last Update Posted: July 27, 2018
Last Verified: June 2018
Keywords provided by GlaxoSmithKline:
Influenza
Children
Hospitalizations
Spain
Burden
Additional relevant MeSH terms:
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Influenza, Human
Emergencies
Orthomyxoviridae Infections
RNA Virus Infections
Virus Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Disease Attributes
Pathologic Processes