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

Gastroenteritis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01171144
• Other study ID #: 111757
• Status: Completed
• Phase: N/A
• First received: July 15, 2010
• Last updated: June 6, 2017
• Start date: January 2009
• Est. completion date: September 2011

Study information

• Verified date: June 2017
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 2011
• Est. primary completion date: September 2011
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 59 Months

Eligibility

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:

Related Conditions & MeSH terms

• Diarrhea
• Gastroenteritis

Intervention

Other:
• Epidemiologic Surveillance System of the Ministry of Health of Panama
Reviewing the Epidemiologic Surveillance System of the Ministry of Health of Panama
• Mortality database of the Contraloria General de la Republica
Reviewing the Mortality database of the Contraloria General de la Republica
• Hospital discharge records
Reviewing the hospital discharge records

Locations

Country	Name	City	State
Panama	GSK Investigational Site	Panama

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Panama, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of all cause reported gastroenteritis		In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
Primary	Occurrence of all cause gastroenteritis related hospital discharges		In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)
Primary	Occurrence of all cause gastroenteritis related deaths.		In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)
Secondary	Occurrence of all cause gastroenteritis-related cases by year, age groups and region		From 1990 to 2010
Secondary	Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting		From 2000 to 2010
Secondary	Occurrence of all cause gastroenteritis related deaths by year, age groups and region		From 1990 to 2010