GastroenteritisNCT03271593
Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study
An observational study of Gastroenteritis, run by GlaxoSmithKline.
Trial summary
The impact of rotavirus vaccination on the burden of disease has been well documented. However, the anticipated reduction in hospital pressures has yet to be described. This study will provide quantitative measures of hospital pressure prior to and post vaccine introduction, provide a template for future hospital… Read more about this study
- Who is it for?
- Ages Up to 15 years
- Conditions the study is for
- Gastroenteritis
- How many people
- 1 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2015to 23 Sep 2016
- 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 15 years
- All sexes
- No healthy volunteers
- Child
Study population: Children <15 years admitted to Alder Hey Children's NHS Foundation Trust. Four sub-populations: All admissions for any cause; Admission for an infectious disease; Admission for all cause gastroenteritis; Admission for Rotavirus gastroenteritis
Who may be able to join
- All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period
Who cannot join
- None
About this study
The impact of rotavirus vaccination on the burden of disease has been well documented. However, the anticipated reduction in hospital pressures has yet to be described. This study will provide quantitative measures of hospital pressure prior to and post vaccine introduction, provide a template for future hospital pressures studies related to vaccine introduction and provide measures which could be used in an economic evaluation.
- Conditions
- Gastroenteritis
- Being tested
- No intervention
- Medical subject headings
- Gastroenteritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
No interventionOther
No intervention
| Study group | Role | What they receive |
|---|---|---|
| All children admitted | All children admitted to hospital Receives: Other: No intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in bed day occupancy (BDO) rates
BDO rate is measured as the number of bed days occupied divided by the total number of bed days available in a ward during a fixed time period. BDO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Measured: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Change in turnover (TO) rates
TO rate is the change in average hospital duration measured as average number of days stay per admission. TO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Measured: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Change in early unplanned readmission (UR) rates
UR rate (within 7 days after discharge) is measured as the number of readmissions ≤7 days after discharge (x100) divided by the total number of discharges. UR rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Measured: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Change in rate of nosocomial infections (NOSO)
NOSO rate is measured as positive test from a test taken >2 days after admission. NOSO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Measured: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Change in number of rotavirus gastroenteritis (RVAG) tests taken
RVAG rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Measured: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Change in number of positive test results
Number of positive RVAG test results will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Measured: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Change in rate of hospitalization in children less that 5 years old
Change in rate of hospitalization (in children less that 5 years old) will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Measured: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Secondary outcomes (1)
Development of a Quality of Care (QoC) score
To develop the QoC score, a baseline rate/score for each outcome measure out-of-season (June-December) will be developed pre-vaccine introduction (vaccine introduction: 30th July 2013). Each outcome measure in the pre-vaccine period and post-vaccine period in-peak-season (January to May) will be scaled against that score. An overall QoC-Score pre- and post-vaccine in peak season will be calculated by summing scores for each outcome measure
Measured: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2017
- Study start2 Nov 2015
- Primary completion23 Sep 2016
- Study completion23 Sep 2016
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 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
- 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
- NCT03271593
- Sponsor's protocol ID
- 205369
- Status last verified
- Sep 2017
- First submitted
- 5 Aug 2016
- Last updated
- 21 Sep 2017
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heinsbroek E, Hungerford D, Cooke RPD, Chowdhury M, Cargill JS, Bar-Zeev N, French N, Theodorou E, Standaert B, Cunliffe NA. Do hospital pressures change following rotavirus vaccine introduction? A retrospective database analysis in a large paediatric hospital in the UK. BMJ Open. 2019 May 15;9(5):e027739. doi: 10.1136/bmjopen-2018-027739.
PubMed 31097487
Study at a glance
From the registry record, last updated by the sponsor on 21 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Rotavirus Vaccination on Hospital Pressures at a Large Paediatric Hospital in the UK: an Ecological Study
- ClinicalTrials.gov ID
- NCT03271593
- Acronym / sponsor ID
- 205369
- Conditions
- Gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2015 (actual)
- Primary completion
- 23 Sep 2016 (actual)
- Study completion
- 23 Sep 2016 (actual)
- First posted
- 5 Sep 2017 (actual)
- 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 impact of rotavirus vaccination on the burden of disease has been well documented. However, the anticipated reduction in hospital pressures has yet to be described. This study will provide quantitative measures of hospital pressure prior to and post vaccine introduction, provide a template for future hospital pressures studies related to vaccine introduction and provide measures which could be used in an economic evaluation.
Study design
- Observational model
- Ecologic or community
- Time perspective
- Retrospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| All children admitted | – | Other: No interventionAll children admitted to hospital |
Who may qualify
- Ages
- Up to 15 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children <15 years admitted to Alder Hey Children's NHS Foundation Trust. Four sub-populations: All admissions for any cause; Admission for an infectious disease; Admission for all cause gastroenteritis; Admission for Rotavirus gastroenteritis
Key inclusion criteria (1 listed)
- All children aged ≤15 years being hospitalised (with overnight stay or day clinic) for whatever reason during the study period
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| No interventionNo intervention | Other | All children admitted |
Primary outcome
Change in bed day occupancy (BDO) rates
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
BDO rate is measured as the number of bed days occupied divided by the total number of bed days available in a ward during a fixed time period. BDO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Change in turnover (TO) rates
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
TO rate is the change in average hospital duration measured as average number of days stay per admission. TO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Change in early unplanned readmission (UR) rates
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
UR rate (within 7 days after discharge) is measured as the number of readmissions ≤7 days after discharge (x100) divided by the total number of discharges. UR rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Change in rate of nosocomial infections (NOSO)
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
NOSO rate is measured as positive test from a test taken >2 days after admission. NOSO rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Change in number of rotavirus gastroenteritis (RVAG) tests taken
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
RVAG rate will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Change in number of positive test results
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Number of positive RVAG test results will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
Change in rate of hospitalization in children less that 5 years old
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
Change in rate of hospitalization (in children less that 5 years old) will be measured in overall admissions, admissions for infectious disease only, admissions for gastro-enteritis only, admissions for rotavirus induced gastro-enteritis only
1 secondary outcome
Development of a Quality of Care (QoC) score
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
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 21 Sep 2017.
- Derived from this study: PubMed 31097487Heinsbroek E, Hungerford D, Cooke RPD, Chowdhury M, Cargill JS, Bar-Zeev N, French N, Theodorou E, Standaert B, Cunliffe NA. Do hospital pressures change following rotavirus vaccine introduction? A retrospective database analysis in a large paediatric hospital in the UK. BMJ Open. 2019 May 15;9(5):e027739. doi: 10.1136/bmjopen-2018-027739.
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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 Gastroenteritis, 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 1 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 21 Sep 2017. 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?
Change in bed day occupancy (BDO) rates (time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)). The study lists 7 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 NCT03271593, 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 21 Sep 2017.