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NCT01175252 Clinical Trial

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

Gastroenteritis Clinical Trial

Official title:
Time Trend Analysis of Diarrhea-related Hospitalizations and Deaths in Children < 5 Years of Age in Brazil, 1990-2010

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT01175252
Other study ID # 112368
Secondary ID
Status Completed
Phase N/A
First received August 3, 2010
Last updated November 8, 2012
Start date December 2008
Est. completion date June 2012

Study information
Verified date November 2012
Source GlaxoSmithKline
Contact n/a
Is FDA regulated No
Health authority Brazil: ANVISA
Study type Observational

Clinical Trial 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.

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™.

Recruitment information / eligibility
Status Completed
Enrollment 1
Est. completion date June 2012
Est. primary completion date June 2012
Accepts healthy volunteers No
Gender Both
Age group N/A to 5 Years
Eligibility 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:

Study Design

Observational Model: Ecologic or Community, Time Perspective: Retrospective

Related Conditions & MeSH terms

Intervention

Other:
• Database analysis
Review and collect data from database

Locations
Country Name City State
Brazil GSK Investigational Site Belem Pará

Sponsors (1)
Lead Sponsor Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Brazil, 

References & Publications (3)

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.

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, Costa I, Shafi FA, Cunha MH, Ortega-Barria E, Linhares AC, Colindres RE. Trends in hospitalizations from all-cause gastroenteritis in children younger than 5 years of age in Brazil before and after human rotavirus vaccine introduction, 1998-2007. Pediatr Infect Dis J. 2010 Jul;29(7):673-5. doi: 10.1097/INF.0b013e3181da8f23. — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Occurrence of all cause gastroenteritis related hospital discharges and deaths 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) No
Secondary Occurrence of all cause gastroenteritis related hospital discharges and hospital deaths by year, region and age groups From 1998 to 2010 No
Secondary Occurrence of all cause gastroenteritis related deaths by year, region and age groups From 1990 to 2009 No
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