Infections, Rotavirus
Conditions
Keywords
Bulgaria, Primary care settings, Children, Latvia, Acute gastroenteritis
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.
Interventions
OTHERStool sample
Samples will be tested to determine the presence or absence of rotavirus.
OTHERData collection
Log books
Sponsors
GlaxoSmithKline
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
No minimum to 5 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | At the time of enrollment of each subject (Day 0). |
Secondary
| Measure | Time frame |
|---|---|
| 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. | 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. | At the time of enrollment of each subject (Day 0). |
| Number of hospitalisations for RV GE and AGE, reported at the primary care settings. | At the time of phone call follow-up contact (14 to 19 days after enrollment). |
Countries
Bulgaria, Latvia
Outcome results
None listed