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

NCT ID: NCT01175252

Last Updated: 2012-11-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

1 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-12-31

Study Completion Date

2012-06-30

Brief Summary

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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.

Detailed Description

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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™.

Conditions

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Diarrhoea Gastroenteritis

Keywords

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Gastroenteritis

Study Design

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Observational Model Type

ECOLOGIC_OR_COMMUNITY

Study Time Perspective

RETROSPECTIVE

Study Groups

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Gastroenteritis Cohort

All children suffering with gastroenteritis

Database analysis

Intervention Type OTHER

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Interventions

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Database analysis

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Intervention Type OTHER

Eligibility Criteria

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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

* Not applicable
Maximum Eligible Age

5 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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GlaxoSmithKline

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Belém, Pará, Brazil

Site Status

Countries

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Brazil

References

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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.

Reference Type BACKGROUND

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.

Reference Type BACKGROUND
PMID: 20300045 (View on PubMed)

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.

Reference Type BACKGROUND

Other Identifiers

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112368

Identifier Type: -

Identifier Source: org_study_id