Last updated: 11/03/2018 10:23:22
Estimation of the burden of rotavirus gastroenteritis (RV GE) in children less than 5 years in Greece
GSK study ID
109355
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: To estimate the burden of rotavirus gastroenteritis (RV GE) in children < 5 years of age in Greece
Trial description: 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.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.
Timeframe: Approximately 12 months
Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age.
Timeframe: Approximately 12 months
Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age.
Timeframe: Approximately 12 months
Secondary outcomes:
Determination of the age of the children, disease severity, and the seasonal distribution of RV GE among children <5 years of age.
Timeframe: Approximately 12 months
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.
Timeframe: Approximately 12 months
Identification of prevalent genotypes of RV among children <5 years of age.
Timeframe: Approximately 12 months
Interventions:
Procedure/surgery: Stool sample
Other: Data collection
Enrollment:
128
Observational study model:
Cohort
Primary completion date:
2010-05-03
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Rotavirus gastroenteritis
Product
SB444563
Collaborators
Not applicable
Study date(s)
July 2008 to March 2010
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable N/A - 5 years
Accepts healthy volunteers
No
- 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.
- Not applicable.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
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).
Exclusion criteria:
Not applicable.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2010-05-03
Actual study completion date
2010-05-03
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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