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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00489567
Other study ID # 109551
Secondary ID
Status Completed
Phase N/A
First received June 20, 2007
Last updated January 27, 2011
Start date October 2007
Est. completion date October 2008

Study information

Verified date January 2011
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Sweden: Regional Ethical Review Board
Study type Observational

Clinical Trial Summary

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.


Recruitment information / eligibility

Status Completed
Enrollment 642
Est. completion date October 2008
Est. primary completion date October 2008
Accepts healthy volunteers No
Gender Both
Age group N/A to 5 Years
Eligibility 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.

Study Design

Observational Model: Case-Only, Time Perspective: Prospective


Intervention

Procedure:
Blood sample collection


Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
GlaxoSmithKline

Outcome

Type Measure Description Time frame Safety issue
Primary To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age. No
Secondary To determine the gender, age of onset, severity of symptoms and underlying medical conditions in community and nosocomially acquired rotavirus infections No
Secondary 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. No
Secondary To estimate the incidence of liver involvement associated with RV GE and relate this to clinical symptoms in the population under surveillance. No
Secondary 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. No
Secondary 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 No
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