Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile
Two Year (2009-2010) Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years of Age Requiring Emergency Room and Hospital Admission in Two Large Cities in Chile.
1 other identifier
observational
967
1 country
2
Brief Summary
The purpose of this study is to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization) in a large public hospital from Valparaiso and another from Santiago.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2009
Shorter than P25 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2009
CompletedFirst Submitted
Initial submission to the registry
May 6, 2009
CompletedFirst Posted
Study publicly available on registry
May 8, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2010
CompletedMay 1, 2014
April 1, 2014
10 months
May 6, 2009
April 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Proportion of rotavirus VP7 and VP4 genotypes
two years
Secondary Outcomes (1)
Proportion of rotavirus positive episodes
two years
Study Arms (2)
Sotero del Rio
Emergency Room and Hospital based surveillance
Van Buren
Emergency Room and Hospital based surveillance
Eligibility Criteria
Children younger than 5 years of age with acute diarrhea or related diagnosis requiring emergency room and hospital admission in two large cities in Chile
You may qualify if:
- Children with acute diarrhea
- Children younger than 5 years
You may not qualify if:
- Illiterate parents
- Chronic gastrointestinal disease
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Chilelead
- Merck Sharp & Dohme LLCcollaborator
Study Sites (2)
Hospital Van Buren
Valparaíso, Región de Valparaíso, Chile
Hospital Dr Sotero del Rio
Santiago, Santiago Metropolitan, Chile
Related Publications (2)
O'Ryan M, Diaz J, Mamani N, Navarrete M, Vallebuono C. Impact of rotavirus infections on outpatient clinic visits in chile. Pediatr Infect Dis J. 2007 Jan;26(1):41-5. doi: 10.1097/01.inf.0000247104.01291.71.
PMID: 17195704BACKGROUNDO'Ryan M, Perez-Schael I, Mamani N, Pena A, Salinas B, Gonzalez G, Gonzalez F, Matson DO, Gomez J. Rotavirus-associated medical visits and hospitalizations in South America: a prospective study at three large sentinel hospitals. Pediatr Infect Dis J. 2001 Jul;20(7):685-93. doi: 10.1097/00006454-200107000-00009.
PMID: 11465841BACKGROUND
Biospecimen
stool
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Miguel L O'Ryan, MD
Microbiology and Micology Program, Faculty of Medicine, University of Chile
Study Design
- Study Type
- observational
- Observational Model
- CASE ONLY
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Full Professor, Microbiology and Mycology Department of Medicine Faculty, Universidad de Chile.
Study Record Dates
First Submitted
May 6, 2009
First Posted
May 8, 2009
Study Start
May 1, 2009
Primary Completion
March 1, 2010
Study Completion
April 1, 2010
Last Updated
May 1, 2014
Record last verified: 2014-04