Infections, RotavirusNCT01563159
Number of Rotavirus (RV) Related Hospitalizations in Belgium - Season 2010-2011
An observational study of Infections, Rotavirus, run by GlaxoSmithKline.
Trial summary
This study aims to confirm the statistically significant decline in rotavirus related and in acute gastro-enteritis (AGE) related hospital admissions that was observed in 11 participating hospitals, after the introduction of RV vaccines in Belgium in 2006. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Infections, Rotavirus
- What is being tested?
- Data collection
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 31 Mar 2015to 31 Dec 2017
- 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 aged ≤5 years undergoing a RV detection test across 11 participating hospitals.
Who may be able to join
- Child aged ≤5 years;
- A stool sample has been provided for a rotavirus detection test during the study period;
- Laboratory test result of rotavirus is available.
Who cannot join
- Not applicable.
About this study
Official title: Assessing the Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)
This study aims to confirm the statistically significant decline in rotavirus related and in acute gastro-enteritis (AGE) related hospital admissions that was observed in 11 participating hospitals, after the introduction of RV vaccines in Belgium in 2006.
Read the detailed description
This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2010 until the 31st of May 2011. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.
- Conditions
- Infections, Rotavirus
- Being tested
- Data collection
- Keywords
- Belgium, hospitals, Rotavirus
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Data collectionOther
Each participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2010- May 31st 2011) and analysed for rotavirus, in children aged ≤5 years.
| Study group | Role | What they receive |
|---|---|---|
| Group A | All children ≤ 5 years old with a rotavirus detection test (inpatient and ambulatory tests) performed during the period of June the 1st 2010 and May the 31st 2011. Receives: Other: Data collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Absolute number of rotavirus related hospitalisations in children up to five years old.
Measured: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
Secondary outcomes (2)
Proportion of rotavirus positive tests on the total number of rota detection tests
Total number of rota detection tests and number of rotavirus positive tests of the study year will be determined by age-group of 1-year, gender, time of the event, vaccine coverage status.
Measured: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
The duration of rota-related hospitalisation for community acquired and nosocomial infection.
Measured: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2012 (estimated)
- Study start31 Mar 2015
- Primary completion31 Dec 2017
- Study completion31 Dec 2017
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 Infections, RotavirusStudies 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
- Ecologic or community
- Time perspective
- Retrospective
- Enrolment
- 1 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
- NCT01563159
- Sponsor's protocol ID
- 116312
- Status last verified
- Mar 2018
- First submitted
- 1 Mar 2012
- Last updated
- 14 Mar 2018
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Standaert B, Strens D, Pereira P, Benninghoff B, Raes M. Lessons Learned from Long-Term Assessment of Rotavirus Vaccination in a High-Income Country: The Case of the Rotavirus Vaccine Belgium Impact Study (RotaBIS). Infect Dis Ther. 2020 Dec;9(4):967-980. doi: 10.1007/s40121-020-00345-y. Epub 2020 Oct 6.
PubMed 33025558
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessing the Rotavirus Positive Test Results in 11 Hospitals in Belgium From 2005 to 2013: the RotaBIS Study (Rotavirus Belgian Impact Study)
- ClinicalTrials.gov ID
- NCT01563159
- Acronym / sponsor ID
- 116312
- Conditions
- Infections, Rotavirus
- Keywords
- Belgium, hospitals, Rotavirus
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2015 (actual)
- Primary completion
- 31 Dec 2017 (actual)
- Study completion
- 31 Dec 2017 (actual)
- First posted
- 26 Mar 2012 (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 confirm the statistically significant decline in rotavirus related and in acute gastro-enteritis (AGE) related hospital admissions that was observed in 11 participating hospitals, after the introduction of RV vaccines in Belgium in 2006.
Detailed description
This retrospective study will use anonymised data, extracted from hospital databases during the period of the 1st of June 2010 until the 31st of May 2011. IMS Health sales data will be used to provide rotavirus vaccine coverage estimates (Rotarix and Rotateq) for the Belgian population during the study period. Any additional source of vaccine coverage status describing rotavirus vaccine uptake in the study population will also be reported.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Group A | – | Other: Data collectionAll children ≤ 5 years old with a rotavirus detection test (inpatient and ambulatory tests) performed during the period of June the 1st 2010 and May the 31st 2011. |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children aged ≤5 years undergoing a RV detection test across 11 participating hospitals.
Key inclusion criteria (3 listed)
- Child aged ≤5 years;
- A stool sample has been provided for a rotavirus detection test during the study period;
- Laboratory test result of rotavirus is available.
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 |
|---|---|---|
| Data collectionEach participating centre will be requested to generate a coded list of all stool samples taken during the study period (June 1st 2010- May 31st 2011) and analysed for rotavirus, in children aged ≤5 years. | Other | Group A |
Primary outcome
Absolute number of rotavirus related hospitalisations in children up to five years old.
Time frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
2 secondary outcomes
Proportion of rotavirus positive tests on the total number of rota detection tests
Time frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
The duration of rota-related hospitalisation for community acquired and nosocomial infection.
Time frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)
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 14 Mar 2018.
- Derived from this study: PubMed 33025558Standaert B, Strens D, Pereira P, Benninghoff B, Raes M. Lessons Learned from Long-Term Assessment of Rotavirus Vaccination in a High-Income Country: The Case of the Rotavirus Vaccine Belgium Impact Study (RotaBIS). Infect Dis Ther. 2020 Dec;9(4):967-980. doi: 10.1007/s40121-020-00345-y. Epub 2020 Oct 6.
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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
Questions about this trial
What is this clinical trial studying?
An observational study of 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 3 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 14 Mar 2018. 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?
Absolute number of rotavirus related hospitalisations in children up to five years old. (time frame: During the study period (from June 1st 2010 to May 31st 2011, i.e. up to 1 year)). 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 NCT01563159, 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 14 Mar 2018.