Last updated: 11/03/2018 10:28:41
Hospital-based surveillance to collect prospective data to estimate the disease burden of severe RV GE in Sweden
GSK study ID
109551
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: A Hospital-based surveillance to collect prospective data to estimate the disease burden of severe RV GE, its complications and diversity of co-circulating rotavirus strains in children < 5 years of age in Sweden
Trial description: This study aims to estimate the burden of RV GE. The study will focus on children hospitalized for severe RV GE, Children acquiring RV GE in the hospital and the household contacts of children hospitalized with RV GE. It is expected to enrol 500-600 subjects in the study. The Protocol Posting has been updated in order to comply with the FDA Amendment Act, Sep 2007.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age.
Timeframe: not applicable
Secondary outcomes:
To determine the gender, age of onset, severity of symptoms and underlying medical conditions in community and nosocomially acquired rotavirus infections
Timeframe: not applicable
To check the incidence of RV antigenemia and viremia associated with severe RV GE and relate this to clinical symptoms and rate of complications in population under surveillance.
Timeframe: not applicable
To estimate the incidence of liver involvement associated with RV GE and relate this to clinical symptoms in the population under surveillance.
Timeframe: not applicable
To explore the possible role of anti-secretory factor in children with RV GE and relate this to clinical symptoms and rate of complications under surveillance.
Timeframe: not applicable
To genotype the isolated rotavirus strains and evaluate a possible correlation to evolved antigenemia, liver involvement and complications in both nosocomially and community-acquired cases with infection of different strain
Timeframe: not applicable
Interventions:
Enrollment:
642
Primary completion date:
Not applicable
Observational study model:
Case-Only
Time perspective:
Prospective
Clinical publications:
Not applicable
Medical condition
Rotavirus gastroenteritis
Product
SB444563
Collaborators
Not applicable
Study date(s)
October 2007 to October 2008
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
Not applicable N/A - 5 years
Accepts healthy volunteers
No
- Written informed consent obtained from parent or guardian
- A male/ female child aged less than 5 years. On the day of fifth birthday the subject is not eligible for participation
- All children in the neonatal wards.
Inclusion and exclusion criteria
Inclusion criteria:
- Written informed consent obtained from parent or guardian
- A male/ female child aged less than 5 years. On the day of fifth birthday the subject is not eligible for participation
- Hospitalised for acute GE
- Developed symptoms of acute GE 72 hours after hospitalisation
- Stool sample should be positive for the presence of rotavirus, which will be detected either by Vikia test or by ELISA Inclusion criteria for household members:
- Family members including care-takers and sibling staying in the same house and who spend most of the nights (50%) with the sick child.
- Written permission from care-takers or siblings or their parents.
Exclusion criteria:
- All children in the neonatal wards.
Trial location(s)
This study does not involve prospective enrollment of participants.
Study documents
No study documents available.
Results overview
No study documents available
Recruitment status
Study complete
Actual primary completion date
Not applicable
Actual study completion date
2008-14-10
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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