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Trends Over Time (1990-2010) of Diarrhoea-related Incidence, Hospitalizations and Deaths in Children of Panama

This study has been completed.
Sponsor:
Information provided by:
GlaxoSmithKline
ClinicalTrials.gov Identifier:
NCT01171144
First received: July 15, 2010
Last updated: September 15, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition Intervention
Gastroenteritis
 Other: Epidemiologic Surveillance System of the Ministry of Health of Panama
Other: Mortality database of the Contraloria General de la Republica
Other: Hospital discharge records

Study Type: Observational
Study Design: Time Perspective: Retrospective
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Occurrence of all cause reported gastroenteritis [ Time Frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005) ] [ Designated as safety issue: No ]
  • Occurrence of all cause gastroenteritis related hospital discharges [ Time Frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005) ] [ Designated as safety issue: No ]
  • Occurrence of all cause gastroenteritis related deaths. [ Time Frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Occurrence of all cause gastroenteritis-related cases by year, age groups and region [ Time Frame: From 1990 to 2010 ] [ Designated as safety issue: No ]
  • Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting [ Time Frame: From 2000 to 2010 ] [ Designated as safety issue: No ]
  • Occurrence of all cause gastroenteritis related deaths by year, age groups and region [ Time Frame: From 1990 to 2010 ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

No samples are retained.


Enrollment: 1
Study Start Date: January 2009
Study Completion Date: September 2011
Primary Completion Date: September 2011 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Gastroenteritis Group
All children suffering with gastroenteritis
 Other: Epidemiologic Surveillance System of the Ministry of Health of Panama
Reviewing the Epidemiologic Surveillance System of the Ministry of Health of Panama
Other: Mortality database of the Contraloria General de la Republica
Reviewing the Mortality database of the Contraloria General de la Republica
Other: Hospital discharge records
Reviewing the hospital discharge records

Detailed Description:

Data will be collected from systematic review of the databases of epidemiologic surveillance system, hospital discharges and deaths for all cause gastroenteritis related outcomes.

  Eligibility

Ages Eligible for Study:   up to 59 Months
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

All children <5 years of age reported with gastroenteritis, gastroenteritis related hospital discharges and gastroenteritis related deaths in Panama, between 1990 and 2010.

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01171144

Locations
Panama
GSK Investigational Site
Panama, Panama
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: Cheri Hudson; Clinical Disclosure Advisor, GSK Clinical Disclosure
ClinicalTrials.gov Identifier: NCT01171144     History of Changes
Other Study ID Numbers: 111757
Study First Received: July 15, 2010
Last Updated: September 15, 2011
Health Authority: Panama: Ministerio de Salud

Additional relevant MeSH terms:
Gastroenteritis
Gastrointestinal Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on October 17, 2012