Last updated: 11/07/2018 03:50:40
Trends over time (1990-2010) of diarrhoea-related incidence, hospitalizations and deaths in children of Panama
Clinicaltrials.gov ID
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Study complete
Study complete
Trial overview
Official title: Time Trend Analysis of Diarrhoea-related Incidence, Hospitalizations, and Deaths in Children < 5 Years of Age in Panama by Monitoring Secondary Data Sources From 1990-2010
Trial description: This study aims at collecting data from secondary sources to obtain baseline incidence and monitor trends over time (1990 - 2010) of reported gastroenteritis cases, gastroenteritis related hospital discharges and gastroenteritis related deaths in children < 5 years of age in Panama before and after implementation of Rotarix™ universal mass vaccination.
Primary purpose:
Not applicable
Trial design:
Not applicable
Masking:
Not applicable
Allocation:
Not applicable
Primary outcomes:
Occurrence of all cause reported gastroenteritis
Timeframe: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
Occurrence of all cause gastroenteritis related hospital discharges
Timeframe: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)
Occurrence of all cause gastroenteritis related deaths.
Timeframe: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
Secondary outcomes:
Occurrence of all cause gastroenteritis-related cases by year, age groups and region
Timeframe: From 1990 to 2010
Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting
Timeframe: From 2000 to 2010
Occurrence of all cause gastroenteritis related deaths by year, age groups and region
Timeframe: From 1990 to 2010
Interventions:
Enrollment:
1
Primary completion date:
2011-08-09
Observational study model:
Other
Time perspective:
Retrospective
Clinical publications:
Bayard V et al. Gastroenteritis-related mortality reduction in Panama after rotavirus vaccine introduction. Abstract presented at the 14th Congreso Sociedad Latinoamericano de Infectologia Pediatrica (SLIPE). Punta Cana, Dominican Republic, 25-28 May 2011.
Medical condition
Gastroenteritis
Product
SB444563
Collaborators
Not applicable
Study date(s)
January 2009 to September 2011
Type
Observational
Phase
Not applicable
Participation criteria
Sex
Female & Male
Age
0 - 59 months
Accepts healthy volunteers
No
- Diarrhea cases, diarrhea associated hospital discharges, and diarrhea related deaths occurring in children <5 years of age during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, in the mortality database of the Contraloría General de la República and in the hospital discharge records of the selected hospitals, will be collected for the study.
- Not applicable
Inclusion and exclusion criteria
Inclusion criteria:
- Diarrhea cases, diarrhea associated hospital discharges, and diarrhea related deaths occurring in children <5 years of age during the period analyzed and registered in the Epidemiologic Surveillance System of the Ministry of Health, in the mortality database of the Contraloría General de la República and in the hospital discharge records of the selected hospitals, will be collected for the study.
Exclusion criteria:
- Not applicable
Trial location(s)
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Study complete
Actual primary completion date
2011-08-09
Actual study completion date
2011-08-09
Plain language summaries
Not applicable. GSK’s transparency policy provides for Plain Language Summaries for Interventional studies.
Additional information about the trial
Not applicable
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