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Trends Over Time (1990-2010) of Diarrhoea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil

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ClinicalTrials.gov Identifier: NCT01175252
Recruitment Status : Completed
First Posted : August 4, 2010
Last Update Posted : November 12, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
Brief Summary:
This study aims at collecting data to obtain baseline incidence and monitor trends over time in hospitalizations and deaths from all cause gastroenteritis in children <5 years of age, before and after implementation of Rotarix™ universal mass vaccination in Brazil.

Condition or disease Intervention/treatment
Diarrhoea Gastroenteritis Other: Database analysis

Detailed Description:
In this study baseline gastroenteritis related hospital discharges and mortality data from the Ministry of Health databases (DATASUS) will be compared to the current data after introduction of Rotarix™.

Study Design

Study Type : Observational
Actual Enrollment : 1 participants
Observational Model: Ecologic or Community
Time Perspective: Retrospective
Official Title: Time Trend Analysis of Diarrhea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil, 1990-2010
Study Start Date : December 2008
Primary Completion Date : June 2012
Study Completion Date : June 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort Intervention/treatment
Gastroenteritis Cohort
All children suffering with gastroenteritis
Other: Database analysis
Review and collect data from database


Outcome Measures

Primary Outcome Measures :
  1. Occurrence of all cause gastroenteritis related hospital discharges and deaths [ Time Frame: In post vaccine introduction period compared to pre-vaccination period (gastroenteritis related hospital discharges from 1998 to 2010, gastroenteritis related deaths from 1990 to 2009) ]

Secondary Outcome Measures :
  1. Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups [ Time Frame: From 1998 to 2010 ]
  2. Occurrence of all cause gastroenteritis related deaths by year, region and age groups [ Time Frame: From 1990 to 2009 ]

Eligibility Criteria

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
All children <5 years of age being hospitalized due to gastroenteritis between 1998 and 2010 and deceased due to gastroenteritis between 1990 and 2009 in Brazil.
Criteria

Inclusion Criteria:

  • Gastroenteritis associated hospital discharges and gastroenteritis related deaths occurring in children <5 years of age during the period analyzed and registered in the DATASUS databases 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): NCT01175252


Locations
Brazil
GSK Investigational Site
Belem, Pará, Brazil, 66 090 000
Sponsors and Collaborators
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
More Information

Publications:
Lanzieri TM et al. The impact of rotavirus vaccination on gastroenteritis hospitalizations among children <5 years in Brazil. Abstract presented at the 6th World Congress of World Society for Pediatric Infectious Diseases (WSPID). Buenos Aires, Argentina, 18-22 November 2009.
Lanzieri TM et al. Impact of rotavirus vaccination on childhood diarrheal deaths in Brazil. Abstract presented at the 9th International Rotavirus Symposium (IRS). Johannesburg, South Africa, 2-3 August 2010.

Responsible Party: GlaxoSmithKline
ClinicalTrials.gov Identifier: NCT01175252     History of Changes
Other Study ID Numbers: 112368
First Posted: August 4, 2010    Key Record Dates
Last Update Posted: November 12, 2012
Last Verified: November 2012

Keywords provided by GlaxoSmithKline:
Gastroenteritis

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