Rotavirus GastroenteritisNCT00489567
Hospital-based Surveillance to Collect Prospective Data to Estimate the Disease Burden of Severe RV GE in Sweden
An observational study of Rotavirus Gastroenteritis and Infections, Rotavirus, run by GlaxoSmithKline.
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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Rotavirus Gastroenteritis, Infections, Rotavirus
- What is being tested?
- Blood sample collection
- Type of treatment
- Surgery or procedure
- How many people
- 642 participants
- Where
- No sites listed yet
- Study dates
- Oct 2007to Oct 2008
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children < 5 years of age in Sweden
Who may be able to join
- 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
- 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.
Who cannot join
- All children in the neonatal wards.
About this study
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
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.
- Conditions
- Rotavirus Gastroenteritis, Infections, Rotavirus
- Being tested
- Blood sample collection
- Keywords
- Rotavirus gastroenteritis
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood sample collectionProcedure or surgery
| Study group | Role | What they receive |
|---|---|---|
| Group A | Children hospitalised with community-acquired severe RV GE and children acquiring nosocomial severe RV GE. Receives: Procedure: Blood sample collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age.
Secondary outcomes (5)
To determine the gender, age of onset, severity of symptoms and underlying medical conditions in community and nosocomially acquired rotavirus infections
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.
To estimate the incidence of liver involvement associated with RV GE and relate this to clinical symptoms in the population under surveillance.
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.
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jun 2007 (estimated)
- Study startOct 2007
- Primary completionOct 2008
- Study completionOct 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus GastroenteritisStudies of the same condition, open and under way.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 642 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00489567
- Sponsor's protocol ID
- 109551
- Status last verified
- Jan 2011
- First submitted
- 20 Jun 2007
- Last updated
- 31 Jan 2011
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jan 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00489567
- Acronym / sponsor ID
- 109551
- Conditions
- Rotavirus Gastroenteritis, Infections, Rotavirus
- Keywords
- Rotavirus gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 642 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Oct 2007
- Primary completion
- Oct 2008 (actual)
- Study completion
- Oct 2008 (actual)
- First posted
- 21 Jun 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Procedure: Blood sample collectionChildren hospitalised with community-acquired severe RV GE and children acquiring nosocomial severe RV GE. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children < 5 years of age in Sweden
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (1 listed)
- All children in the neonatal wards.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood sample collection | Procedure or surgery | Group A |
Primary outcome
To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age.
5 secondary outcomes
To determine the gender, age of onset, severity of symptoms and underlying medical conditions in community and nosocomially acquired rotavirus infections
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.
To estimate the incidence of liver involvement associated with RV GE and relate this to clinical symptoms in the population under surveillance.
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.
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jan 2011.
Related trials for Rotavirus Gastroenteritis
RecruitingPhase 2
PhaseⅡClinical Trial of Oral Hexavalent Reassortant Rotavirus Attenuated Live Vaccine (Vero Cells)
Rotavirus Gastroenteritis
Recruiting
Artificial Intelligence-driven Virtual Standardized Pediatric Patients Trial
Pneumococcal Pneumonia, Rotavirus Enteritis With Hypovolemic Shock
Active, not recruitingPhase 2
Safety and Immunogenicity Study of Recombinant Trivalent Rotavirus Subunit Vaccine in Healthy Infants and Toddlers
Rotavirus Infections, Rotavirus Gastroenteritis
Active, not recruitingPhase 4
Optimising Rotavirus Vaccine in Aboriginal Children
Viral Gastroenteritis Due to Rotavirus
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
GSK Clinical Trials study director
GlaxoSmithKline
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Gastroenteritis and Infections, Rotavirus, run by GlaxoSmithKline.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 Jan 2011. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To estimate the incidence of severe rotavirus gastroenteritis (RV GE) and its associated complications in children < 5 years of age.. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jan 2011.