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

12. juni 2018 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

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.

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

501

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Spanien
      • Bilbao, Spanien, 48013
        • GSK Investigational Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

Ikke ældre end 15 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Andet
  • Tildeling: N/A
  • Interventionel model: Enkelt gruppeopgave
  • Maskning: Ingen (Åben etiket)

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Andet: 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.
Andet: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects With Laboratory-confirmed Influenza Presenting With an Acute Respiratory Illness (ARI) and/or Isolated Fever
Tidsramme: 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.
Day 0 till Day 28-37
Direct Medical Cost Per Hospitalization or ER Visit With Laboratory-confirmed Influenza
Tidsramme: 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.
Day 0 till Day 28-37

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Number of Subjects With Other Laboratory-confirmed Respiratory Viruses
Tidsramme: 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.
Day 0 till Day 28-37
Number of Subjects With Fatal Outcomes
Tidsramme: Day 0 till Day 28-37
Deaths from ARI and/or fever episodes by laboratory-confirmed influenza status were assessed.
Day 0 till Day 28-37
Number of Subjects With Secondary Bacterial Infections
Tidsramme: Day 0 till Day 28-37
The outcome assessed the various complications by laboratory-confirmed influenza status.
Day 0 till Day 28-37
Number of Subjects With Potential Risk Factors at Study Start by Laboratory-confirmed Influenza Status
Tidsramme: Day 0 till Day 28-37
Risk factors were classified as pre-existing conditions, breast-feeding status and day-care status.
Day 0 till Day 28-37
Number of Days of Hospitalization
Tidsramme: Day 0 till Day 28-37 (between October 2010 until May 2011)
The outcomes was assessed in subjects with laboratory-confirmed influenza status
Day 0 till Day 28-37 (between October 2010 until May 2011)
Number of Subjects Using Any ARI and/or Fever Related Medication Taken Prior to Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Tidsramme: Day 0 till Day 28-37
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Day 0 till Day 28-37
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed During Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Tidsramme: Day 0 till Day 28-37
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Day 0 till Day 28-37
Number of Subjects Using Any ARI and/or Fever Related Medication Prescribed Since Hospitalization or ER Visit by Laboratory-confirmed Influenza Status
Tidsramme: Day 0 till Day 28-37
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Day 0 till Day 28-37
Number of Subjects Using Any Non-prescribed ARI and/or Fever Related Medication Taken Since Hospitalization or ER Visit
Tidsramme: Day 0 till Day 28-37
ARI and/or fever related medication included: antivirals, antibiotics, cough suppressants, pain medication, antipyretics and mucolytics.
Day 0 till Day 28-37
Number of Days of School Absenteeism
Tidsramme: Day 0 till Day 28-37
School absenteeism was assessed among patients during the follow-up period by laboratory-confirmed influenza status.
Day 0 till Day 28-37
Number of Days of Parent or Caregiver Time Off Work
Tidsramme: 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.
Day 0 till Day 28-37
Number of Subjects With Household Members With Influenza-like Illness
Tidsramme: 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.
Day 0 till Day 28-37
Proportion of Household Members Presenting Influenza Like Illness Symptoms (ARI and/or Isolated Fever)
Tidsramme: 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.
Day 0 till Day 28-37

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

GlaxoSmithKline

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

23. november 2010

Primær færdiggørelse (Faktiske)

23. maj 2011

Studieafslutning (Faktiske)

23. maj 2011

Datoer for studieregistrering

Først indsendt

3. maj 2012

Først indsendt, der opfyldte QC-kriterier

3. maj 2012

Først opslået (Skøn)

7. maj 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

27. juli 2018

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

12. juni 2018

Sidst verificeret

1. juni 2018

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 114004

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Kliniske forsøg med Influenza

Kliniske forsøg med Throat swab and/or nasopharyngeal swab

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Kenya

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner