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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:
ClinicalTrials.gov Identifier:
NCT01171144
First Posted: July 28, 2010
Last Update Posted: June 7, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
GlaxoSmithKline
  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: Observational Model: Other
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:


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) ]
  • Occurrence of all cause gastroenteritis related hospital discharges [ Time Frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005) ]
  • Occurrence of all cause gastroenteritis related deaths. [ Time Frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005) ]

Secondary Outcome Measures:
  • Occurrence of all cause gastroenteritis-related cases by year, age groups and region [ Time Frame: From 1990 to 2010 ]
  • Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting [ Time Frame: From 2000 to 2010 ]
  • Occurrence of all cause gastroenteritis related deaths by year, age groups and region [ Time Frame: From 1990 to 2010 ]

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

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 59 Months   (Child)
Sexes Eligible for Study:   All
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:

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01171144


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

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01171144     History of Changes
Other Study ID Numbers: 111757
First Submitted: July 15, 2010
First Posted: July 28, 2010
Last Update Posted: June 7, 2017
Last Verified: June 2017

Additional relevant MeSH terms:
Diarrhea
Gastroenteritis
Signs and Symptoms, Digestive
Signs and Symptoms
Gastrointestinal Diseases
Digestive System Diseases