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A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia

16. januar 2017 opdateret af: GlaxoSmithKline

An Observational Study to Estimate the Disease Burden of Rotavirus Gastroenteritis in Infants/Children Less Than Five Years of Age in Primary Care Settings, in Bulgaria and Latvia

This study aims to estimate the real situation of rotavirus gastroenteritis (RV GE) in the primary care settings of both Bulgaria and Latvia in children less than 5 years of age.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Detaljeret beskrivelse

A Primary care setting will include independent general practitioners (GP) (specialised in paediatrics) or independent paediatricians.

Stool samples will be collected from all enrolled subjects at Visit 1 (Day 0) and tested immediately after collection. The stool sample will be stored for 24 hours only, in case the test cannot be performed immediately after collection.

Undersøgelsestype

Observationel

Tilmelding (Faktiske)

1266

Kontakter og lokationer

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

Studiesteder

  • Bulgarien
      • Burgas, Bulgarien, 8000
        • GSK Investigational Site
      • Burgas, Bulgarien, 8018
        • GSK Investigational Site
      • Dobrich, Bulgarien, 9300
        • GSK Investigational Site
      • Pazardzik, Bulgarien, 4400
        • GSK Investigational Site
      • Pleven, Bulgarien, 5800
        • GSK Investigational Site
      • Plovdiv, Bulgarien, 4000
        • GSK Investigational Site
      • Ruse, Bulgarien, 7000
        • GSK Investigational Site
      • Sliven, Bulgarien, 8800
        • GSK Investigational Site
      • Sofia, Bulgarien, 1606
        • GSK Investigational Site
      • Sofia, Bulgarien, 1505
        • GSK Investigational Site
      • Sofia, Bulgarien, 1517
        • GSK Investigational Site
      • Sofia, Bulgarien, 1528
        • GSK Investigational Site
      • Stara Zagora, Bulgarien, 6000
        • GSK Investigational Site
      • Varna, Bulgarien, 9000
        • GSK Investigational Site
      • Veliko Turnovo, Bulgarien, 5000
        • GSK Investigational Site
  • Letland
      • Balvi, Letland, LV-4501
        • GSK Investigational Site
      • Bauska, Letland, LV-3901
        • GSK Investigational Site
      • Broceni, Letland, LV-3851
        • GSK Investigational Site
      • Carnikava, Letland, LV-2163
        • GSK Investigational Site
      • Daugavpils, Letland, LV-5401
        • GSK Investigational Site
      • Daugavpils, Letland, LV-5410
        • GSK Investigational Site
      • Druva, Letland, LV-3862
        • GSK Investigational Site
      • Erglu pagasts, Letland, LV-4840
        • GSK Investigational Site
      • Grobina, Letland, LV-3430
        • GSK Investigational Site
      • Ikskile, Letland, LV-5052
        • GSK Investigational Site
      • Jekabpils, Letland, LV-5201
        • GSK Investigational Site
      • Jelgava, Letland, LV-3001
        • GSK Investigational Site
      • Jelgava, Letland, LV-3002
        • GSK Investigational Site
      • Jelgava, Letland, LV-3007
        • GSK Investigational Site
      • Jelgava, Letland, LV-3008
        • GSK Investigational Site
      • Kuldiga, Letland, LV-3300
        • GSK Investigational Site
      • Liepaja, Letland, LV-3401
        • GSK Investigational Site
      • Limbazi, Letland, LV-4001
        • GSK Investigational Site
      • Livani, Letland, LV-5316
        • GSK Investigational Site
      • Madona, Letland, LV-4801
        • GSK Investigational Site
      • Ogre, Letland, LV-5001
        • GSK Investigational Site
      • Ozolnieki, Letland, LV-3018
        • GSK Investigational Site
      • Pinki, Letland, LV-2107
        • GSK Investigational Site
      • Rezekne, Letland, LV-4601
        • GSK Investigational Site
      • Rezekne, Letland, LV-4604
        • GSK Investigational Site
      • Riga, Letland, LV-1001
        • GSK Investigational Site
      • Riga, Letland, LV-1002
        • GSK Investigational Site
      • Riga, Letland, LV-1010
        • GSK Investigational Site
      • Riga, Letland, LV-1011
        • GSK Investigational Site
      • Riga, Letland, LV-1012
        • GSK Investigational Site
      • Riga, Letland, LV-1024
        • GSK Investigational Site
      • Riga, Letland, LV-1050
        • GSK Investigational Site
      • Riga, Letland, LV-1063
        • GSK Investigational Site
      • Riga, Letland, LV-1082
        • GSK Investigational Site
      • Ropazi, Letland, LV-2135
        • GSK Investigational Site
      • Sigulda, Letland, LV-2150
        • GSK Investigational Site
      • Tukums, Letland, LV-3101
        • GSK Investigational Site
      • Valmiera, Letland, LV-4200
        • GSK Investigational Site
      • Valmiera, Letland, LV-4201
        • GSK Investigational Site
      • Vangazi, Letland, LV-2136
        • GSK Investigational Site
      • Ventspils, Letland, LV-3601
        • GSK Investigational Site
      • Ventspils, Letland, LV-3602
        • 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 5 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Infants/children less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.

Beskrivelse

Inclusion Criteria:

  • Infants/children with home visits by the GPGP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for AGE treatment during the study period.
  • A male or female infant/child less than five years of age at the time of the GP/paediatrician visit. A child becomes ineligible on the day of her/his fifth birthday.
  • Written informed consent obtained from the parents/legally acceptable representative (LARs) of the subject.
  • Subjects who the investigator believes that his/her, parents/LARs can and will comply with the requirements of the protocol.

Exclusion Criteria:

• Child in care.

Studieplan

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

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Observationsmodeller: Kohorte
  • Tidsperspektiver: Fremadrettet

Kohorter og interventioner

Gruppe / kohorte
Intervention / Behandling
Group Bulgaria
Subjects in this group include infants/children from Bulgaria, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
Andet: Stool sample
Samples will be tested to determine the presence or absence of rotavirus.
Andet: Data collection
Log books
Group Latvia
Subjects in this group include infants/children from Latvia, less than five years of age with home visits by the GP/paediatrician for the treatment of AGE or brought to the GP/paediatrician for the treatment of AGE.
Andet: Stool sample
Samples will be tested to determine the presence or absence of rotavirus.
Andet: Data collection
Log books

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Number of RV GE cases among the acute gastroenteritis (AGE) cases reported at primary care settings in infants/children less than five years of age.
Tidsramme: At the time of enrollment of each subject (Day 0).
At the time of enrollment of each subject (Day 0).

Sekundære resultatmål

Resultatmål
Tidsramme
Symptoms related to AGE and their measures, stratified by rotavirus status for all the AGE cases reported by infants/children less than five years of age at the primary care settings.
Tidsramme: Day 0 - Day 14+5 (At the time of phone call follow-up contact).
Day 0 - Day 14+5 (At the time of phone call follow-up contact).
Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.
Tidsramme: At the time of enrollment of each subject (Day 0).
At the time of enrollment of each subject (Day 0).
Number of hospitalisations for RV GE and AGE, reported at the primary care settings.
Tidsramme: At the time of phone call follow-up contact (14 to 19 days after enrollment).
At the time of phone call follow-up contact (14 to 19 days after enrollment).

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. december 2012

Primær færdiggørelse (Faktiske)

1. juni 2014

Studieafslutning (Faktiske)

1. juni 2014

Datoer for studieregistrering

Først indsendt

21. november 2012

Først indsendt, der opfyldte QC-kriterier

26. november 2012

Først opslået (Skøn)

27. november 2012

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

18. januar 2017

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

16. januar 2017

Sidst verificeret

1. januar 2017

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 116621

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 .

Kliniske forsøg med Infektioner, Rotavirus

Kliniske forsøg med Stool sample

Søg i lignende forsøg

Sponsorer og samarbejdspartnere

Medicinske tilstande

Narkotikainterventioner

CROs by country

CROs in Pakistan

Betingelser

Sjældne sygdomme

Narkotikainterventioner

Kosttilskud

Sponsor / samarbejdspartnere

Placeringer

Abonner