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Two-year Surveillance of Rotavirus Genotypes Causing Acute Diarrhea in Children Younger Than 5 Years Requiring Emergency Room (ER) and Hospital Admission in Chile

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT00895492
Recruitment Status : Completed
First Posted : May 8, 2009
Last Update Posted : May 1, 2014
Sponsor:
Collaborator:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Acute Diarrheal Disease Rotavirus Infection

Detailed Description:
Rotavirus is the leading cause of gastroenteritis in children. Our group has developed a surveillance system for acute rotavirus diarrhea in two large hospitals in Chile since 2006. Patients visiting the ER for acute non-bloody diarrhea will be enrolled after an informed consent is signed by parents. A fresh stool sample will be collected to prospectively determine the rotavirus VP7/VP4 genotypes associated with moderate to severe disease (requiring emergency room (ER) consult or hospitalization. Stool samples will be tested for rotavirus by ELISA IDEIA - Rotavirus - OXOID. Rotavirus positive samples will be genotyped as described previously (Iturriza-Gomara et al. J. Clinical Virol 2004). Overall medical visits and hospitalizations, proportion of visits and hospitalizations caused by acute diarrhea, estimated numbers of rotavirus visits and hospitalizations will be calculated for each site. Proportion of rotavirus VP7 and VP4 genotypes will be calculated for three month periods per center. Differences in proportion will be compared by chi square and Fischer's exact test when appropriate.

Study Design

Study Type : Observational
Actual Enrollment : 967 participants
Observational Model: Case-Only
Time Perspective: Prospective
Official Title: 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.
Study Start Date : May 2009
Primary Completion Date : March 2010
Study Completion Date : April 2010

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Sotero del Rio
Emergency Room and Hospital based surveillance
Van Buren
Emergency Room and Hospital based surveillance


Outcome Measures

Primary Outcome Measures :
  1. Proportion of rotavirus VP7 and VP4 genotypes [ Time Frame: two years ]

Secondary Outcome Measures :
  1. Proportion of rotavirus positive episodes [ Time Frame: two years ]

Biospecimen Retention:   Samples With DNA
stool

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   1 Month to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
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
Criteria

Inclusion Criteria:

  • Children with acute diarrhea
  • Children younger than 5 years

Exclusion Criteria:

  • Illiterate parents
  • Chronic gastrointestinal disease
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): NCT00895492


Locations
Chile
Hospital Dr Sotero del Rio
Santiago, Metropolitana, Chile
Hospital Van Buren
Valparaiso, Chile
Sponsors and Collaborators
University of Chile
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Miguel L O'Ryan, MD Microbiology and Micology Program, Faculty of Medicine, University of Chile
More Information

Publications:
Responsible Party: Miguel O'Ryan Gallardo, Full Professor, Microbiology and Mycology Department of Medicine Faculty, Universidad de Chile., University of Chile
ClinicalTrials.gov Identifier: NCT00895492     History of Changes
Other Study ID Numbers: Merck 2009
First Posted: May 8, 2009    Key Record Dates
Last Update Posted: May 1, 2014
Last Verified: April 2014

Keywords provided by Miguel O'Ryan Gallardo, University of Chile:
diarrhea
rotavirus
genotype
VP4
VP7

Additional relevant MeSH terms:
Emergencies
Diarrhea
Rotavirus Infections
Disease Attributes
Pathologic Processes
Signs and Symptoms, Digestive
Signs and Symptoms
Reoviridae Infections
RNA Virus Infections
Virus Diseases