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

This study has been completed.
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Miguel O'Ryan Gallardo, University of Chile
ClinicalTrials.gov Identifier:
NCT00895492
First received: May 6, 2009
Last updated: April 30, 2014
Last verified: April 2014
  Purpose

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
Acute Diarrheal Disease
Rotavirus Infection

Study Type: Observational
Study Design: 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.

Resource links provided by NLM:


Further study details as provided by University of Chile:

Primary Outcome Measures:
  • Proportion of rotavirus VP7 and VP4 genotypes [ Time Frame: two years ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Proportion of rotavirus positive episodes [ Time Frame: two years ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

stool


Enrollment: 967
Study Start Date: May 2009
Study Completion Date: April 2010
Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
Groups/Cohorts
Sotero del Rio
Emergency Room and Hospital based surveillance
Van Buren
Emergency Room and Hospital based surveillance

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.

  Eligibility

Ages Eligible for Study:   1 Month to 5 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
Study First Received: May 6, 2009
Last Updated: April 30, 2014
Health Authority: Chile: Hospital Dr. Sotero del Río IRB

Keywords provided by University of Chile:
diarrhea
rotavirus
genotype
VP4
VP7

Additional relevant MeSH terms:
Diarrhea
Rotavirus Infections
Signs and Symptoms, Digestive
Signs and Symptoms
Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014