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Completed

NCT Number: NCT00751686

Estimation of the Burden of Rotavirus Gastroenteritis (RV GE) in Children Less Than 5 Years in Greece

The purpose of this study is to measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data. In addition, data collected will determine the seasonal distribution, disease severity, age distribution of RV GE. From an economic standpoint, the cost and impact of RV will also be assessed.

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Key information

Conditions

Rotavirus Gastroenteritis Digestive System Diseases Gastroenteritis Gastrointestinal Diseases

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site, Athens, Greece

Loading trial locations.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • A male or female child < 5 years of age at the time of the visit (a child becomes ineligible on the day of her/his 5th birthday).
  • Child is brought to the emergency room for acute GE during the study period or develop acute GE at least 48 hours after hospitalisation.
  • Written informed consent obtained from the parent/guardian of the subject.
  • Children with RV positive stool sample will be enrolled in the study.

Exclusion criteria

  • Not applicable.

Treatment and study plan

Stool sample

Procedure

Collection of the stool at least 48 hours after hospitalisation. Stool samples should be obtained preferably within 4 and no later than 10 days after the onset of the GE symptoms.

Data Collection

Other

Logbook, Health Economic Questionnaire, Telephone call.

Primary outcomes

  1. Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.

    Time frame: Approximately 12 months

  2. Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age.

    Time frame: Approximately 12 months

  3. Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age.

    Time frame: Approximately 12 months

Secondary outcomes

  1. Determination of the age of the children, disease severity, and the seasonal distribution of RV GE among children <5 years of age.

    Time frame: Approximately 12 months

  2. Assessing the costs related to the episodes of RV GE, by the completion of the Health Economic Questionnaire (interview with the parent for a subset of subjects) and the cost checklist provided by the hospital's site staff.

    Time frame: Approximately 12 months

  3. Identification of prevalent genotypes of RV among children <5 years of age.

    Time frame: Approximately 12 months

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

To Estimate the Burden of Rotavirus Gastroenteritis (RV GE) in Children < 5 Years of Age in Greece

Important dates

Study start
2008
Primary completion
2010
Study completion
2010
First posted
Sep 12, 2008
Registry last updated
Feb 18, 2013

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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