Clinical trial NCT01733849: A Study to Estimate the Occurrence of Rotavirus Gastroenteritis in Children < 5 Years of Age, in Bulgaria and Latvia
Official title: 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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Bulgaria
Primary care settings
Children
Latvia
Acute gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2012-11-27
Enrollment: 1266
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: 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.
timeFrame: At the time of enrollment of each subject (Day 0).
Secondary outcomes:
measure: 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.
timeFrame: Day 0 - Day 14+5 (At the time of phone call follow-up contact).
measure: Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.
timeFrame: At the time of enrollment of each subject (Day 0).
measure: Number of hospitalisations for RV GE and AGE, reported at the primary care settings.
timeFrame: At the time of phone call follow-up contact (14 to 19 days after enrollment).
Other outcomes:
Locations:
city: Burgas
country: Bulgaria
facility: GSK Investigational Site
city: Burgas
country: Bulgaria
facility: GSK Investigational Site
city: Dobrich
country: Bulgaria
facility: GSK Investigational Site
city: Pazardzik
country: Bulgaria
facility: GSK Investigational Site
city: Pleven
country: Bulgaria
facility: GSK Investigational Site
city: Plovdiv
country: Bulgaria
facility: GSK Investigational Site
city: Ruse
country: Bulgaria
facility: GSK Investigational Site
city: Sliven
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Sofia
country: Bulgaria
facility: GSK Investigational Site
city: Stara Zagora
country: Bulgaria
facility: GSK Investigational Site
city: Varna
country: Bulgaria
facility: GSK Investigational Site
city: Veliko Turnovo
country: Bulgaria
facility: GSK Investigational Site
city: Balvi
country: Latvia
facility: GSK Investigational Site
city: Bauska
country: Latvia
facility: GSK Investigational Site
city: Broceni
country: Latvia
facility: GSK Investigational Site
city: Carnikava
country: Latvia
facility: GSK Investigational Site
city: Daugavpils
country: Latvia
facility: GSK Investigational Site
city: Daugavpils
country: Latvia
facility: GSK Investigational Site
city: Druva
country: Latvia
facility: GSK Investigational Site
city: Erglu pagasts
country: Latvia
facility: GSK Investigational Site
city: Grobina
country: Latvia
facility: GSK Investigational Site
city: Ikskile
country: Latvia
facility: GSK Investigational Site
city: Jekabpils
country: Latvia
facility: GSK Investigational Site
city: Jelgava
country: Latvia
facility: GSK Investigational Site
city: Jelgava
country: Latvia
facility: GSK Investigational Site
city: Jelgava
country: Latvia
facility: GSK Investigational Site
city: Jelgava
country: Latvia
facility: GSK Investigational Site
city: Kuldiga
country: Latvia
facility: GSK Investigational Site
city: Liepaja
country: Latvia
facility: GSK Investigational Site
city: Limbazi
country: Latvia
facility: GSK Investigational Site
city: Livani
country: Latvia
facility: GSK Investigational Site
city: Madona
country: Latvia
facility: GSK Investigational Site
city: Ogre
country: Latvia
facility: GSK Investigational Site
city: Ozolnieki
country: Latvia
facility: GSK Investigational Site
city: Pinki
country: Latvia
facility: GSK Investigational Site
city: Rezekne
country: Latvia
facility: GSK Investigational Site
city: Rezekne
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Riga
country: Latvia
facility: GSK Investigational Site
city: Ropazi
country: Latvia
facility: GSK Investigational Site
city: Sigulda
country: Latvia
facility: GSK Investigational Site
city: Tukums
country: Latvia
facility: GSK Investigational Site
city: Valmiera
country: Latvia
facility: GSK Investigational Site
city: Valmiera
country: Latvia
facility: GSK Investigational Site
city: Vangazi
country: Latvia
facility: GSK Investigational Site
city: Ventspils
country: Latvia
facility: GSK Investigational Site
city: Ventspils
country: Latvia
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.
citation: 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.