Study on the Burden of Influenza-related Hospitalizations and Emergency Room (ER) Visits in Children in Spain
12 juni 2018 uppdaterad av: GlaxoSmithKline
Burden of Influenza-related Hospitalizations and Emergency Room Visits in Children in Spain
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.
Studieöversikt
Status
Avslutad
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Interventionell
Inskrivning (Faktisk)
501
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studieorter
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Bilbao, Spanien, 48013
- GSK Investigational Site
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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
Inte äldre än 15 år (Barn)
Tar emot friska volontärer
Nej
Kön som är behöriga för studier
Allt
Beskrivning
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.
Studieplan
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Övrig
- Tilldelning: N/A
- Interventionsmodell: Enskild gruppuppgift
- Maskning: Ingen (Open Label)
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Övrig: 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.
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Samples will be tested to quantify the inpatient and ER visits burden of laboratory-confirmed influenza.
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.
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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
Tidsram: Day 0 till Day 28-37
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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.
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Day 0 till Day 28-37
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Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
Tidsram: Day 0 till Day 28-37
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Ward specific room charge and Intensive Care Unit (ICU) were computed as daily charge multiplied by the number of days.
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Day 0 till Day 28-37
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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
Tidsram: Day 0 till Day 28-37
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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.
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Day 0 till Day 28-37
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Number of Subjects With Fatal Outcomes
Tidsram: Day 0 till Day 28-37
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Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
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Day 0 till Day 28-37
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Number of Subjects With Secondary Bacterial Infections
Tidsram: Day 0 till Day 28-37
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The outcome assessed the various complications by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
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Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
Tidsram: Day 0 till Day 28-37
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Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
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Day 0 till Day 28-37
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Number of Days of Hospitalization
Tidsram: Day 0 till Day 28-37 (between October 2010 until May 2011)
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The outcomes was assessed in subjects with laboratory-confirmed influenza status
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Day 0 till Day 28-37 (between October 2010 until May 2011)
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Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Tidsram: Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
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Day 0 till Day 28-37
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Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Tidsram: Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
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Day 0 till Day 28-37
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Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Tidsram: Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
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Day 0 till Day 28-37
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Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit
Tidsram: Day 0 till Day 28-37
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ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
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Day 0 till Day 28-37
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Number of Days of School Absenteeism
Tidsram: Day 0 till Day 28-37
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School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
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Number of Days of Parent or Caregiver Time Off Work
Tidsram: Day 0 till Day 28-37
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This outcome assessed absenteeism among caregivers to provide patient care during the follow-up period by laboratory-confirmed influenza status.
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Day 0 till Day 28-37
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Number of Subjects With Household Members With Influenza-like Illness
Tidsram: Day 0 till Day 28-37
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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.
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Day 0 till Day 28-37
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Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
Tidsram: Day 0 till Day 28-37
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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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Day 0 till Day 28-37
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Samarbetspartners och utredare
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Sponsor
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart
23 november 2010
Primärt slutförande (Faktisk)
23 maj 2011
Avslutad studie (Faktisk)
23 maj 2011
Studieregistreringsdatum
Först inskickad
3 maj 2012
Först inskickad som uppfyllde QC-kriterierna
3 maj 2012
Första postat (Uppskatta)
7 maj 2012
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
27 juli 2018
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
12 juni 2018
Senast verifierad
1 juni 2018
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- 114004
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