Last updated: 11/03/2018 11:15:00
Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates
GSK study ID
110846
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Finalized
Finalized
Trial overview
Official title: An Observational, Hospital-based Surveillance to Estimate the Disease Burden of Acute Rotavirus (RV) Gastroenteritis (GE) in Children < 5 Years of Age in United Arab Emirates (UAE).
Trial description: The purpose of this study is to estimate the disease burden and epidemiology of rotavirus gastroenteritis in children less than 5 years of age, in United Arab Emirates. Acute gastroenteritis cases will be identified from acute gastroenteritis hospitalisation log book and stool samples will be collected from all suspected and confirmed acute gastroenteritis cases.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.
Timeframe: Twelve months from study initiation
Secondary outcomes:
Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age.
Timeframe: Twelve months from study initiation
Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis.
Timeframe: Twelve months from study initiation
Distribution of different strains of rotavirus in children < 5 years of age.
Timeframe: Twelve months from study initiation
Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age.
Timeframe: Twelve months from study initiation
Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age.
Timeframe: Twelve months from study initiation
Interventions:
Procedure/surgery: Stool sampling
Enrollment:
717
Observational study model:
Case-Only
Primary completion date:
2010-19-07
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Rotaviral gastroenteritis
Product
SB444563
Collaborators
Not applicable
Study date(s)
July 2009 to July 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 < 5 years of age at the time of admission to the study hospital for acute gastroenteritis.
- Written informed consent obtained from the parent or guardian of the subject.
- The diagnosis for treatment at the study site does not include acute gastroenteritis.
- The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent obtained from the parent or guardian of the subject.
A male or female < 5 years of age at the time of admission to the study hospital for acute gastroenteritis.
Exclusion criteria:
- The onset of acute gastroenteritis after admission to the hospital i.e. 48 hours after hospital admission.
The diagnosis for treatment at the study site does not include acute gastroenteritis.
Trial location(s)
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Finalized
Actual primary completion date
2010-19-07
Actual study completion date
2010-19-07
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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