A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia
16 januari 2017 bijgewerkt door: 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.
Studie Overzicht
Toestand
Voltooid
Conditie
Interventie / Behandeling
Gedetailleerde beschrijving
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
Observationeel
Inschrijving (Werkelijk)
1266
Contacten en locaties
In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.
Studie Locaties
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Burgas, Bulgarije, 8000
- GSK Investigational Site
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Burgas, Bulgarije, 8018
- GSK Investigational Site
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Dobrich, Bulgarije, 9300
- GSK Investigational Site
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Pazardzik, Bulgarije, 4400
- GSK Investigational Site
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Pleven, Bulgarije, 5800
- GSK Investigational Site
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Plovdiv, Bulgarije, 4000
- GSK Investigational Site
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Ruse, Bulgarije, 7000
- GSK Investigational Site
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Sliven, Bulgarije, 8800
- GSK Investigational Site
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Sofia, Bulgarije, 1606
- GSK Investigational Site
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Sofia, Bulgarije, 1505
- GSK Investigational Site
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Sofia, Bulgarije, 1517
- GSK Investigational Site
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Sofia, Bulgarije, 1528
- GSK Investigational Site
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Stara Zagora, Bulgarije, 6000
- GSK Investigational Site
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Varna, Bulgarije, 9000
- GSK Investigational Site
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Veliko Turnovo, Bulgarije, 5000
- GSK Investigational Site
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Balvi, Letland, LV-4501
- GSK Investigational Site
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Bauska, Letland, LV-3901
- GSK Investigational Site
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Broceni, Letland, LV-3851
- GSK Investigational Site
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Carnikava, Letland, LV-2163
- GSK Investigational Site
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Daugavpils, Letland, LV-5401
- GSK Investigational Site
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Daugavpils, Letland, LV-5410
- GSK Investigational Site
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Druva, Letland, LV-3862
- GSK Investigational Site
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Erglu pagasts, Letland, LV-4840
- GSK Investigational Site
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Grobina, Letland, LV-3430
- GSK Investigational Site
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Ikskile, Letland, LV-5052
- GSK Investigational Site
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Jekabpils, Letland, LV-5201
- GSK Investigational Site
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Jelgava, Letland, LV-3001
- GSK Investigational Site
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Jelgava, Letland, LV-3002
- GSK Investigational Site
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Jelgava, Letland, LV-3007
- GSK Investigational Site
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Jelgava, Letland, LV-3008
- GSK Investigational Site
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Kuldiga, Letland, LV-3300
- GSK Investigational Site
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Liepaja, Letland, LV-3401
- GSK Investigational Site
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Limbazi, Letland, LV-4001
- GSK Investigational Site
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Livani, Letland, LV-5316
- GSK Investigational Site
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Madona, Letland, LV-4801
- GSK Investigational Site
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Ogre, Letland, LV-5001
- GSK Investigational Site
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Ozolnieki, Letland, LV-3018
- GSK Investigational Site
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Pinki, Letland, LV-2107
- GSK Investigational Site
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Rezekne, Letland, LV-4601
- GSK Investigational Site
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Rezekne, Letland, LV-4604
- GSK Investigational Site
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Riga, Letland, LV-1001
- GSK Investigational Site
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Riga, Letland, LV-1002
- GSK Investigational Site
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Riga, Letland, LV-1010
- GSK Investigational Site
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Riga, Letland, LV-1011
- GSK Investigational Site
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Riga, Letland, LV-1012
- GSK Investigational Site
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Riga, Letland, LV-1024
- GSK Investigational Site
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Riga, Letland, LV-1050
- GSK Investigational Site
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Riga, Letland, LV-1063
- GSK Investigational Site
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Riga, Letland, LV-1082
- GSK Investigational Site
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Ropazi, Letland, LV-2135
- GSK Investigational Site
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Sigulda, Letland, LV-2150
- GSK Investigational Site
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Tukums, Letland, LV-3101
- GSK Investigational Site
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Valmiera, Letland, LV-4200
- GSK Investigational Site
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Valmiera, Letland, LV-4201
- GSK Investigational Site
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Vangazi, Letland, LV-2136
- GSK Investigational Site
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Ventspils, Letland, LV-3601
- GSK Investigational Site
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Ventspils, Letland, LV-3602
- GSK Investigational Site
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Deelname Criteria
Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Niet ouder dan 5 jaar (Kind)
Accepteert gezonde vrijwilligers
Nee
Geslachten die in aanmerking komen voor studie
Allemaal
Bemonsteringsmethode
Niet-waarschijnlijkheidssteekproef
Studie Bevolking
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.
Beschrijving
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.
Studie plan
Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.
Hoe is de studie opgezet?
Ontwerpdetails
- Observatiemodellen: Cohort
- Tijdsperspectieven: Prospectief
Cohorten en interventies
Groep / Cohort |
Interventie / Behandeling |
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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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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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.
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Tijdsspanne |
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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.
Tijdsspanne: 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.
Tijdsspanne: 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.
Tijdsspanne: 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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Medewerkers en onderzoekers
Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.
Sponsor
Publicaties en nuttige links
De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.
Algemene publicaties
- 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.
Studie record data
Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.
Bestudeer belangrijke data
Studie start
1 december 2012
Primaire voltooiing (Werkelijk)
1 juni 2014
Studie voltooiing (Werkelijk)
1 juni 2014
Studieregistratiedata
Eerst ingediend
21 november 2012
Eerst ingediend dat voldeed aan de QC-criteria
26 november 2012
Eerst geplaatst (Schatting)
27 november 2012
Updates van studierecords
Laatste update geplaatst (Schatting)
18 januari 2017
Laatste update ingediend die voldeed aan QC-criteria
16 januari 2017
Laatst geverifieerd
1 januari 2017
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- 116621
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