CompletedNot Applicable

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

Bulgaria1,266 participantsStarted 2012-12

Plain-language 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.

Who can participate

Age range5 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

What they're measuring

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).

Trial details

NCT IDNCT01733849

SponsorGlaxoSmithKline

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2014-06

View on ClinicalTrials.gov More Infections, Rotavirus trials