A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia
16. januar 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Observasjonsmessig
Registrering (Faktiske)
1266
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
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Burgas, Bulgaria, 8000
- GSK Investigational Site
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Burgas, Bulgaria, 8018
- GSK Investigational Site
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Dobrich, Bulgaria, 9300
- GSK Investigational Site
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Pazardzik, Bulgaria, 4400
- GSK Investigational Site
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Pleven, Bulgaria, 5800
- GSK Investigational Site
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Plovdiv, Bulgaria, 4000
- GSK Investigational Site
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Ruse, Bulgaria, 7000
- GSK Investigational Site
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Sliven, Bulgaria, 8800
- GSK Investigational Site
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Sofia, Bulgaria, 1606
- GSK Investigational Site
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Sofia, Bulgaria, 1505
- GSK Investigational Site
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Sofia, Bulgaria, 1517
- GSK Investigational Site
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Sofia, Bulgaria, 1528
- GSK Investigational Site
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Stara Zagora, Bulgaria, 6000
- GSK Investigational Site
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Varna, Bulgaria, 9000
- GSK Investigational Site
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Veliko Turnovo, Bulgaria, 5000
- GSK Investigational Site
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Balvi, Latvia, LV-4501
- GSK Investigational Site
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Bauska, Latvia, LV-3901
- GSK Investigational Site
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Broceni, Latvia, LV-3851
- GSK Investigational Site
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Carnikava, Latvia, LV-2163
- GSK Investigational Site
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Daugavpils, Latvia, LV-5401
- GSK Investigational Site
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Daugavpils, Latvia, LV-5410
- GSK Investigational Site
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Druva, Latvia, LV-3862
- GSK Investigational Site
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Erglu pagasts, Latvia, LV-4840
- GSK Investigational Site
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Grobina, Latvia, LV-3430
- GSK Investigational Site
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Ikskile, Latvia, LV-5052
- GSK Investigational Site
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Jekabpils, Latvia, LV-5201
- GSK Investigational Site
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Jelgava, Latvia, LV-3001
- GSK Investigational Site
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Jelgava, Latvia, LV-3002
- GSK Investigational Site
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Jelgava, Latvia, LV-3007
- GSK Investigational Site
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Jelgava, Latvia, LV-3008
- GSK Investigational Site
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Kuldiga, Latvia, LV-3300
- GSK Investigational Site
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Liepaja, Latvia, LV-3401
- GSK Investigational Site
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Limbazi, Latvia, LV-4001
- GSK Investigational Site
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Livani, Latvia, LV-5316
- GSK Investigational Site
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Madona, Latvia, LV-4801
- GSK Investigational Site
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Ogre, Latvia, LV-5001
- GSK Investigational Site
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Ozolnieki, Latvia, LV-3018
- GSK Investigational Site
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Pinki, Latvia, LV-2107
- GSK Investigational Site
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Rezekne, Latvia, LV-4601
- GSK Investigational Site
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Rezekne, Latvia, LV-4604
- GSK Investigational Site
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Riga, Latvia, LV-1001
- GSK Investigational Site
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Riga, Latvia, LV-1002
- GSK Investigational Site
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Riga, Latvia, LV-1010
- GSK Investigational Site
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Riga, Latvia, LV-1011
- GSK Investigational Site
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Riga, Latvia, LV-1012
- GSK Investigational Site
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Riga, Latvia, LV-1024
- GSK Investigational Site
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Riga, Latvia, LV-1050
- GSK Investigational Site
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Riga, Latvia, LV-1063
- GSK Investigational Site
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Riga, Latvia, LV-1082
- GSK Investigational Site
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Ropazi, Latvia, LV-2135
- GSK Investigational Site
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Sigulda, Latvia, LV-2150
- GSK Investigational Site
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Tukums, Latvia, LV-3101
- GSK Investigational Site
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Valmiera, Latvia, LV-4200
- GSK Investigational Site
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Valmiera, Latvia, LV-4201
- GSK Investigational Site
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Vangazi, Latvia, LV-2136
- GSK Investigational Site
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Ventspils, Latvia, LV-3601
- GSK Investigational Site
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Ventspils, Latvia, LV-3602
- GSK Investigational Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Ikke eldre enn 5 år (Barn)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Prøvetakingsmetode
Ikke-sannsynlighetsprøve
Studiepopulasjon
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Observasjonsmodeller: Kohort
- Tidsperspektiver: Potensielle
Kohorter og intervensjoner
Gruppe / Kohort |
Intervensjon / Behandling |
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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.
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Samples will be tested to determine the presence or absence of rotavirus.
Log books
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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.
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Samples will be tested to determine the presence or absence of rotavirus.
Log books
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
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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).
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At the time of enrollment of each subject (Day 0).
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Sekundære resultatmål
Resultatmål |
Tidsramme |
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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).
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Day 0 - Day 14+5 (At the time of phone call follow-up contact).
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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).
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At the time of enrollment of each subject (Day 0).
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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).
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At the time of phone call follow-up contact (14 to 19 days after enrollment).
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- Tafalla M, Gardovska D, Gopala K, Kozlovska L. Primary care-based surveillance to estimate the proportion of rotavirus gastroenteritis among Latvian children below 5 years of age with acute gastroenteritis. Hum Vaccin Immunother. 2019;15(6):1272-1278. doi: 10.1080/21645515.2018.1534515. Epub 2018 Oct 31.
- Tiholova M, Gopala K, Berberova M, Strokova-Stoilova M, Tafalla M. Rotavirus gastroenteritis in children less than five years of age in primary care settings in Bulgaria: an observational study. Germs. 2016 Sep 1;6(3):97-105. doi: 10.11599/germs.2016.1095. eCollection 2016 Sep.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. desember 2012
Primær fullføring (Faktiske)
1. juni 2014
Studiet fullført (Faktiske)
1. juni 2014
Datoer for studieregistrering
Først innsendt
21. november 2012
Først innsendt som oppfylte QC-kriteriene
26. november 2012
Først lagt ut (Anslag)
27. november 2012
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
18. januar 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
16. januar 2017
Sist bekreftet
1. januar 2017
Mer informasjon
Begreper knyttet til denne studien
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 116621
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .