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

Study Overview
=================
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.

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

Conditions
-----------------
Infections, Rotavirus

Intervention / Treatment
-----------------
* Other: Stool sample
* Other: Data collection


Participation Criteria
=================
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.

Ages Eligible for Study
-----------------
Maximum Age: 5 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Group Bulgaria<br>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. | Other: Stool sample<br>* Samples will be tested to determine the presence or absence of rotavirus.<br>Other: Data collection<br>* Log books<br>|
| Group Latvia<br>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. | Other: Stool sample<br>* Samples will be tested to determine the presence or absence of rotavirus.<br>Other: Data collection<br>* Log books<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | 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 Outcome Measures

| Outcome Measure | Measure Description | 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). | 

 Terms related to the study
=================
Keywords Provided by Centre Hospitalier Valida
-----------------
Bulgaria, Primary care settings, Children, Latvia, Acute gastroenteritis