An observational study in Gastroenteritis, sponsored by GlaxoSmithKline. Completed. Open to participants aged Up to 15 Years. Per ClinicalTrials.gov, last updated 2017-09-21.
Sponsored by GlaxoSmithKline · Observational
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Among 25 studies in Gastroenteritis by GlaxoSmithKline — none open to participants now, none under way, none of them phase 3. Gastroenteritis · GlaxoSmithKline.
Among the 25 studies in Gastroenteritis by GlaxoSmithKline, this one is the 12th largest by enrollment of the 15 observational ones that give a count, is the only one that started in 2015, is one of 15 observational ones, and was the 23rd registered.
237 studies on the registry are indexed under Gastroenteritis; 16 are open to participants now.
Browse Gastroenteritis studies →None of the 25 studies in Gastroenteritis by GlaxoSmithKline is open now. The open studies under Gastroenteritis, anywhere →
Of the 13 Gastroenteritis studies recruiting now, 5 (38%) set no upper age limit and 8 (62%) stop at 75 or younger; 11 take children under 18; 3 take healthy volunteers.
This study: Up to 15 Years · all sexes · no healthy volunteers.
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25 studies; the count open now beside each. This study's row is marked.
First in 2000; this study’s year is marked. 1 started in 2015.
This study's enrollment of 1 is below the median of 606 across 62 observational studies indexed under Gastroenteritis.
Median enrollment 567 across the 10 interventional studies, 643 across the 15 observational. Of the 25 that completed or were terminated, 10 (40%) have results posted.
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GlaxoSmithKline is the lead sponsor of 3,650 studies on the registry; 117 are open to participants now.
Of its 265 completed or terminated interventional studies of FDA-regulated products, 241 (91%) have results posted.
None of the studies under way reaches primary completion within a year.
Among the 25 studies in Gastroenteritis by GlaxoSmithKline, from their registry updates:
Nothing recorded among them since 2026-09-25.
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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.
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
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Exclusion Criteria:
All children admitted to hospital
Other: No intervention
No intervention
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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
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
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
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
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
Time frame: During the study observation period of 15 years (1st July 2000 - 30th June 2015)
No study locations are listed for this record.
Ran from Nov 2015 to primary completion in Sep 2016, 10 months.
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This study is completed, as verified in Sep 2017. You cannot join it, but the record below documents what was studied.
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