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

Completed

• Conditions: Gastroenteritis
• Interventions: 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

• Registration Number: NCT01171144
• Lead Sponsor: GlaxoSmithKline

Brief Summary

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.

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.

Study Timeline

• Study Start: 2009-01
• Study First Submitted: 2010-07-15
• Study First Submitted QC: 2010-07-27
• Study First Posted: 2010-07-28
• Primary Completion: 2011-09
• Study Completion: 2011-09
• Status Verified: 2017-06
• Last Update Submitted: 2017-06-06
• Last Update Posted: 2017-06-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Gastroenteritis Group	Hospital discharge records	All children suffering with gastroenteritis
Gastroenteritis Group	Epidemiologic Surveillance System of the Ministry of Health of Panama	All children suffering with gastroenteritis
Gastroenteritis Group	Mortality database of the Contraloria General de la Republica	All children suffering with gastroenteritis

Primary Outcome Measures

Name	Time	Method
Occurrence of all cause gastroenteritis related hospital discharges	In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)
Occurrence of all cause gastroenteritis related deaths.	In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
Occurrence of all cause reported gastroenteritis	In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)

Secondary Outcome Measures

Name	Time	Method
Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting	From 2000 to 2010
Occurrence of all cause gastroenteritis related deaths by year, age groups and region	From 1990 to 2010
Occurrence of all cause gastroenteritis-related cases by year, age groups and region	From 1990 to 2010

Trial Locations

Locations (1)

GSK Investigational Site; 🇵🇦 Panama, Panama