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Completed

NCT Number: NCT01733849

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

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.

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Key information

Conditions

Infections, Rotavirus Infections RNA Virus Infections Reoviridae Infections Rotavirus Infections Virus Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Burgas, Bulgaria

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Stool sample

Other

Samples will be tested to determine the presence or absence of rotavirus.

Data Collection

Other

Log books

Primary outcomes

  1. 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.

    Time frame: At the time of enrollment of each subject (Day 0).

Secondary outcomes

  1. 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.

    Time frame: Day 0 - Day 14+5 (At the time of phone call follow-up contact).

  2. Number of RV GE cases reported at each month by infants/children less than five years of age reported at the primary care settings.

    Time frame: At the time of enrollment of each subject (Day 0).

  3. Number of hospitalisations for RV GE and AGE, reported at the primary care settings.

    Time frame: At the time of phone call follow-up contact (14 to 19 days after enrollment).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Nov 27, 2012
Registry last updated
Jan 18, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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