Rotaviral GastroenteritisNCT01201252
Study to Estimate the Disease Burden of Acute Rotavirus Gastroenteritis in Children < 5 Years in United Arab Emirates
An observational study of Rotaviral Gastroenteritis, run by GlaxoSmithKline at 3 sites in United Arab Emirates.
Trial summary
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… Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Rotaviral Gastroenteritis
- What is being tested?
- Stool sampling
- Type of treatment
- Surgery or procedure
- How many people
- 717 participants
- Where
- 3 sitesUnited Arab Emirates
- Study dates
- Jul 2009to Jul 2010
- 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 hospitalised with acute gastroenteritis
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
3 sites in 1 country.
United Arab Emirates3 sites
GSK Investigational Site
Abu Dhabi
GSK Investigational Site
Al Ain City
GSK Investigational Site
Sharjah city
About this study
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).
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.
- Conditions
- Rotaviral Gastroenteritis
- Being tested
- Stool sampling
- Keywords
- children, gastroenteritis, Rotavirus
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool samplingProcedure or surgery
Stool samples will be collected, tested and genotyped for the presence of rotavirus
| Study group | Role | What they receive |
|---|---|---|
| Acute gastroenteritis Group | Suspected/confirmed cases of rotavirus gastroenteritis in children < 5 years of age Receives: Procedure: Stool sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.
Measured: Twelve months from study initiation
Secondary outcomes (5)
Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age.
Measured: Twelve months from study initiation
Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis.
Measured: Twelve months from study initiation
Distribution of different strains of rotavirus in children < 5 years of age.
Measured: Twelve months from study initiation
Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age.
Measured: Twelve months from study initiation
Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age.
Measured: Twelve months from study initiation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Sep 2010 (estimated)
- Study startJul 2009
- Primary completionJul 2010
- Study completionJul 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotaviral 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
- 717 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01201252
- Sponsor's protocol ID
- 110846
- Status last verified
- Nov 2012
- First submitted
- 13 Sep 2010
- Last updated
- 19 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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).
- ClinicalTrials.gov ID
- NCT01201252
- Acronym / sponsor ID
- 110846
- Conditions
- Rotaviral Gastroenteritis
- Keywords
- children, gastroenteritis, Rotavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 717 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2009
- Primary completion
- Jul 2010 (actual)
- Study completion
- Jul 2010 (actual)
- First posted
- 14 Sep 2010 (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.
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acute gastroenteritis Group | – | Procedure: Stool samplingSuspected/confirmed cases of rotavirus gastroenteritis in children < 5 years of age |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children < 5 years of age hospitalised with acute gastroenteritis
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
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 |
|---|---|---|
| Stool samplingStool samples will be collected, tested and genotyped for the presence of rotavirus | Procedure or surgery | Acute gastroenteritis Group |
Primary outcome
Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus.
Time frame: Twelve months from study initiation
5 secondary outcomes
Age and seasonal distribution of hospitalisations associated with rotavirus in children < 5 years of age.
Time frame: Twelve months from study initiation
Occurrence of intravenous re-hydration treatment and/or other treatments due to rotavirus gastroenteritis.
Time frame: Twelve months from study initiation
Distribution of different strains of rotavirus in children < 5 years of age.
Time frame: Twelve months from study initiation
Occurrence of acute gastroenteritis and rotavirus gastroenteritis among all hospitalisations of children < 5 years of age.
Time frame: Twelve months from study initiation
Occurrence of severe dehydrating rotavirus gastroenteritis based on Vesikari scale among children < 5 years of age.
Time frame: Twelve months from study initiation
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 19 Nov 2012.
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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
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotaviral Gastroenteritis, run by GlaxoSmithKline at 3 sites in United Arab Emirates.
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 2 inclusion and 2 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 19 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Occurrence of diarrhoeal hospitalisations in children < 5 years of age, which are attributable to rotavirus. (time frame: Twelve months from study initiation). 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 19 Nov 2012.