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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Infections, Rotavirus

Treatments: Other: Data collection; Other: Stool sample

Study type: Observational

Funder types: Industry

Identifiers

NCT01733849

116621

Details and patient eligibility

About

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.

Full 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.

Enrollment: 1,266 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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.

Trial design

1,266 participants in 2 patient groups

Group Bulgaria

Description:

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.

Treatment:

Other: Stool sample

Other: Data collection

Group Latvia

Description:

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.

Treatment:

Other: Stool sample

Other: Data collection