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To Evaluate the Incidence of Acute Otitis Media in Children in Five East European Countries

24. juli 2014 opdateret af: GlaxoSmithKline

To Evaluate Incidence of Acute Otitis Media in Children Aged < 6 Years in Five East European Countries

The aim of this study is to provide baseline acute otitis media data in East European countries.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

Each subject's involvement in this study will include a retrospective and prospective part.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

2258

Kontakter og lokationer

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

Studiesteder

  • Estland
      • Tallinn, Estland, 10621
        • GSK Investigational Site
  • Litauen
      • Vilnius, Litauen, LT-07156
        • GSK Investigational Site
      • Vilnius, Litauen, LT-04318
        • GSK Investigational Site
      • Vilnius, Litauen, LT-03147
        • GSK Investigational Site
  • Polen
      • Bydgoszcz, Polen, 85-796
        • GSK Investigational Site
      • Debica, Polen, 39-200
        • GSK Investigational Site
      • Katowice, Polen, 40-018
        • GSK Investigational Site
      • Kielce, Polen, 25-711
        • GSK Investigational Site
      • Leczna, Polen, 21-010
        • GSK Investigational Site
      • Siemianowice Slaskie, Polen, 41-103
        • GSK Investigational Site
      • Tarnow, Polen, 33-100
        • GSK Investigational Site
      • Warszawa, Polen, 01-809
        • GSK Investigational Site
      • Wejherowo, Polen, 84-200
        • GSK Investigational Site
      • Wola, Polen, 43-225
        • GSK Investigational Site
  • Rumænien
      • Bacau, Rumænien, 600316
        • GSK Investigational Site
      • Brasov, Rumænien, 500260
        • GSK Investigational Site
      • Bucharest, Rumænien, 051821
        • GSK Investigational Site
      • Craiova, Rumænien, 200128
        • GSK Investigational Site
      • Galati, Rumænien, 800394
        • GSK Investigational Site
  • Slovenien
      • Ljubljana, Slovenien, 1000
        • GSK Investigational Site
      • Ljubljana, Slovenien, 1210
        • GSK Investigational Site
      • Maribor, Slovenien, 2000
        • GSK Investigational Site
      • Maribor, Slovenien
        • GSK Investigational Site
      • Ptuj, Slovenien, 2250
        • GSK Investigational Site
      • Ruše, Slovenien, 2342
        • 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 6 år (Barn)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Subjects aged < 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia) will be enrolled in this study.

Beskrivelse

Inclusion Criteria:

  • Subjects who the investigator believes that parent(s)/ legally acceptable representative(s) can and will comply with the requirements of the protocol.
  • A male or female subject aged < 6 years at the time of enrolment.
  • The investigator has access to the medical records that contain the medical history of the subjects for one year prior to enrolment (for subjects aged 1 to < 6 years) or from birth (for subjects aged < 1 year).
  • Written informed consent obtained from either both parents/ LARs or from one parent/ LAR of the subject with the declaration of cooperation for one year after enrolment.

Exclusion Criteria:

  • Acute otitis media episode at the time of enrolment.
  • Upper respiratory tract infection at the time of enrolment.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Cohort A
Subjects aged < 6 years who are registered in primary care clinics of any of the participating countries (Estonia, Lithuania, Poland, Romania and Slovenia).
Andet: Data collection (Retrospective)
For the retrospective part of the study, the parent(s)/ legally acceptable representative(s) of the subjects will be interviewed to collect information on factors potentially related to risk for middle ear diseases. The medical records of the subjects will also be reviewed and all acute otitis media related problems that occurred during the last year prior to enrolment (for subjects aged 1 to < 6 years) or since birth (for subjects aged < 1 year) will be recorded in the electronic case report form.
Andet: Data collection (Prospective)
For the prospective part of the study, the enrolled subjects will be followed up for a period of 1 year starting from the consent date, during which the parent(s)/ legally acceptable representative(s) will be asked to bring the subject for a visit each time they notice symptoms of acute otitis media or respiratory tract infection in the subject. In case AOM is diagnosed by the investigator, detailed information on the signs, symptoms, severity, course and treatment will be recorded. The parent(s)/ legally acceptable representative(s) of the subjects will also be required to fill up a parental quality of life questionnaire and an Otitis Media-6 children's quality of life questionnaire.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by a family physician and documented in medical records - retrospective part of the study
Tidsramme: Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year
Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year
Occurrence of acute otitis media in subjects aged < 6 years as diagnosed by the physician or specialist - prospective part of the study
Tidsramme: Prospective data for 12 months after study entry
Prospective data for 12 months after study entry

Sekundære resultatmål

Resultatmål
Tidsramme
Prevalence of otitis media with effusion among acute otitis media cases aged < 6 years in the four consecutive seasons of the year
Tidsramme: Prospective data for 12 months after study entry
Prospective data for 12 months after study entry
Occurrence of suspected acute otitis media as reported by the parent(s)/ legally acceptable representative(s) (and not diagnosed by any physician) during the bi-monthly follow-up
Tidsramme: Prospective data for 12 months after study entry
Prospective data for 12 months after study entry
Occurrence of recurrent acute otitis media
Tidsramme: Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year and prospective data for 12 months after study entry
Retrospective data for 12 months prior to study entry for subjects aged > 1 year or for the entire period since birth for subjects aged < 1 year and prospective data for 12 months after study entry
Occurrence of acute otitis media treatment failures
Tidsramme: Prospective data for 12 months after study entry
Prospective data for 12 months after study entry
Assessment of the impact of acute otitis media on the quality of life of the subject and family by the parental quality of life questionnaire and the Otitis Media-6 children's quality of life questionnaire
Tidsramme: Prospective data for 12 months after study entry
Prospective data for 12 months after study entry
Direct medical, direct non-medical costs and indirect medical costs of one incident of acute otitis media
Tidsramme: Prospective data for 12 months after study entry
Prospective data for 12 months after study entry
Occurrence of acute otitis media as diagnosed by the study physician or any other doctor
Tidsramme: Prospective data for 12 months after study entry
Prospective data for 12 months after study entry
Use of antimicrobial therapy and other forms of treatment for acute otitis media, diagnostic procedures
Tidsramme: Prospective data for 12 months after study entry
Prospective data for 12 months after study entry

Samarbejdspartnere og efterforskere

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

Sponsor

GlaxoSmithKline

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

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

1. juni 2011

Primær færdiggørelse (Faktiske)

1. december 2012

Studieafslutning (Faktiske)

1. december 2012

Datoer for studieregistrering

Først indsendt

31. maj 2011

Først indsendt, der opfyldte QC-kriterier

1. juni 2011

Først opslået (Skøn)

3. juni 2011

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

28. juli 2014

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

24. juli 2014

Sidst verificeret

1. maj 2014

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 115356

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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