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OpenTrials
Completed

NCT Number: NCT01171144

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

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.

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Key information

Conditions

Gastroenteritis Digestive System Diseases Gastrointestinal Diseases

Age range

Up to 59 month

Sex eligibility

All sexes

Study type

Observational

Primary location

GSK Investigational Site

Panama City, Panama

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Epidemiologic Surveillance System of the Ministry of Health of Panama

Other

Reviewing the Epidemiologic Surveillance System of the Ministry of Health of Panama

Mortality database of the Contraloria General de la Republica

Other

Reviewing the Mortality database of the Contraloria General de la Republica

Hospital discharge records

Other

Reviewing the hospital discharge records

Primary outcomes

  1. Occurrence of all cause reported gastroenteritis

    Time frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)

  2. Occurrence of all cause gastroenteritis related hospital discharges

    Time frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (2000-2005)

  3. Occurrence of all cause gastroenteritis related deaths.

    Time frame: In post vaccine introduction period (2006-2010) compared to pre-vaccination period (1990-2005)

Secondary outcomes

  1. Occurrence of all cause gastroenteritis-related cases by year, age groups and region

    Time frame: From 1990 to 2010

  2. Occurrence of all cause gastroenteritis related hospital discharge by year, age groups, hospital and setting

    Time frame: From 2000 to 2010

  3. Occurrence of all cause gastroenteritis related deaths by year, age groups and region

    Time frame: From 1990 to 2010

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study 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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Jul 28, 2010
Registry last updated
Jun 7, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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