Rotavirus GastroenteritisNCT00751686
Estimation of the Burden of Rotavirus Gastroenteritis (RV GE) in Children Less Than 5 Years in Greece
An observational study of Rotavirus Gastroenteritis, run by GlaxoSmithKline at 6 sites in Greece.
Trial summary
The purpose of this study is to measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data. In addition, data collected will determine the seasonal distribution, disease severity, age distribution of RV GE. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Rotavirus Gastroenteritis
- What is being tested?
- Stool sample and Data collection
- Type of treatment
- Surgery or procedure
- How many people
- 128 participants
- Where
- 6 sitesGreece
- Study dates
- Jul 2008to Mar 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 seen at the selected hospital sites for acute GE (e.g. subjects treated at the hospital or visiting the emergency room for an acute GE episode or developed acute GE at least 48 hours after hospitalisation) with a rapid screen positive test result to RV.
Who may be able to join
- A male or female child < 5 years of age at the time of the visit (a child becomes ineligible on the day of her/his 5th birthday).
- Child is brought to the emergency room for acute GE during the study period or develop acute GE at least 48 hours after hospitalisation.
- Written informed consent obtained from the parent/guardian of the subject.
- Children with RV positive stool sample will be enrolled in the study.
Who cannot join
- Not applicable.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
Greece6 sites
GSK Investigational Site
Athens, 104 46
GSK Investigational Site
Athens, 11527
GSK Investigational Site
Heraklion, Crete, 71409
GSK Investigational Site
Rio/Patras, 26500
GSK Investigational Site
Thessaloniki, 546 38
GSK Investigational Site
Thessaloniki, 54636
About this study
Official title: To Estimate the Burden of Rotavirus Gastroenteritis (RV GE) in Children < 5 Years of Age in Greece
The purpose of this study is to measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data. In addition, data collected will determine the seasonal distribution, disease severity, age distribution of RV GE. From an economic standpoint, the cost and impact of RV will also be assessed.
- Conditions
- Rotavirus Gastroenteritis
- Being tested
- Stool sample, Data collection
- Keywords
- Gastroenteritis, Burden, Rotavirus, < 5 years, Greece, Children
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Stool sampleProcedure or surgery
Collection of the stool at least 48 hours after hospitalisation. Stool samples should be obtained preferably within 4 and no later than 10 days after the onset of the GE symptoms.
Data collectionOther
Logbook, Health Economic Questionnaire, Telephone call.
| Study group | Role | What they receive |
|---|---|---|
| RV GE Group | Not described Receives: Procedure: Stool sample; Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.
Measured: Approximately 12 months
Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age.
Measured: Approximately 12 months
Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age.
Measured: Approximately 12 months
Secondary outcomes (3)
Determination of the age of the children, disease severity, and the seasonal distribution of RV GE among children <5 years of age.
Measured: Approximately 12 months
Assessing the costs related to the episodes of RV GE, by the completion of the Health Economic Questionnaire (interview with the parent for a subset of subjects) and the cost checklist provided by the hospital's site staff.
Measured: Approximately 12 months
Identification of prevalent genotypes of RV among children <5 years of age.
Measured: Approximately 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2008 (estimated)
- Study startJul 2008
- Primary completionMar 2010
- Study completionMar 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 128 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
- NCT00751686
- Sponsor's protocol ID
- 109355
- Status last verified
- Feb 2013
- First submitted
- 11 Sep 2008
- Last updated
- 18 Feb 2013
- Results posted
- No
Publications
Konstantopoulos A, Tragiannidis A, Fouzas S, Kavaliotis I, Tsiatsou O, Michailidou E, Spanaki A, Mantagos S, Kafetzis D, Papaevangelou V, Gopala K, Holl K. Burden of rotavirus gastroenteritis in children <5 years of age in Greece: hospital-based prospective surveillance (2008-2010). BMJ Open. 2013 Dec 11;3(12):e003570. doi: 10.1136/bmjopen-2013-003570.
PubMed 24334153
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- To Estimate the Burden of Rotavirus Gastroenteritis (RV GE) in Children < 5 Years of Age in Greece
- ClinicalTrials.gov ID
- NCT00751686
- Acronym / sponsor ID
- 109355
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- Gastroenteritis, Burden, Rotavirus, < 5 years, Greece, Children
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- Jul 2008
- Primary completion
- Mar 2010 (actual)
- Study completion
- Mar 2010 (actual)
- First posted
- 12 Sep 2008 (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 measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data. In addition, data collected will determine the seasonal distribution, disease severity, age distribution of RV GE. From an economic standpoint, the cost and impact of RV will also be assessed.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| RV GE Group | – | Procedure: Stool sample, Other: Data collection |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children < 5 years of age seen at the selected hospital sites for acute GE (e.g. subjects treated at the hospital or visiting the emergency room for an acute GE episode or developed acute GE at least 48 hours after hospitalisation) with a rapid screen positive test result to RV.
Key inclusion criteria (4 listed)
- A male or female child < 5 years of age at the time of the visit (a child becomes ineligible on the day of her/his 5th birthday).
- Child is brought to the emergency room for acute GE during the study period or develop acute GE at least 48 hours after hospitalisation.
- Written informed consent obtained from the parent/guardian of the subject.
- Children with RV positive stool sample will be enrolled in the study.
Key exclusion criteria (1 listed)
- Not applicable.
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 sampleCollection of the stool at least 48 hours after hospitalisation. Stool samples should be obtained preferably within 4 and no later than 10 days after the onset of the GE symptoms. | Procedure or surgery | RV GE Group |
| Data collectionLogbook, Health Economic Questionnaire, Telephone call. | Other | RV GE Group |
Primary outcome
Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.
Time frame: Approximately 12 months
Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age.
Time frame: Approximately 12 months
Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age.
Time frame: Approximately 12 months
3 secondary outcomes
Determination of the age of the children, disease severity, and the seasonal distribution of RV GE among children <5 years of age.
Time frame: Approximately 12 months
Assessing the costs related to the episodes of RV GE, by the completion of the Health Economic Questionnaire (interview with the parent for a subset of subjects) and the cost checklist provided by the hospital's site staff.
Time frame: Approximately 12 months
Identification of prevalent genotypes of RV among children <5 years of age.
Time frame: Approximately 12 months
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 18 Feb 2013.
- Derived from this study: PubMed 24334153Konstantopoulos A, Tragiannidis A, Fouzas S, Kavaliotis I, Tsiatsou O, Michailidou E, Spanaki A, Mantagos S, Kafetzis D, Papaevangelou V, Gopala K, Holl K. Burden of rotavirus gastroenteritis in children <5 years of age in Greece: hospital-based prospective surveillance (2008-2010). BMJ Open. 2013 Dec 11;3(12):e003570. doi: 10.1136/bmjopen-2013-003570.
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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
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Rotavirus Gastroenteritis, run by GlaxoSmithKline at 6 sites in Greece.
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 4 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 18 Feb 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in Greece. 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?
Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age. (time frame: Approximately 12 months). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00751686, which also lists 1 linked publication.
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 18 Feb 2013.