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

NCT ID: NCT00895492

Last Updated: 2014-05-01

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 967 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2009-05-31
• Study Completion Date: 2010-04-30

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.

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.

Conditions

Acute Diarrheal Disease; Rotavirus Infection

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

Sotero del Rio

Emergency Room and Hospital based surveillance

No interventions assigned to this group

Van Buren

Emergency Room and Hospital based surveillance

No interventions assigned to this group

Eligibility Criteria

Inclusion Criteria

• Children with acute diarrhea
• Children younger than 5 years

Exclusion Criteria

• Illiterate parents
• Chronic gastrointestinal disease

• Minimum Eligible Age: 1 Month
• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: collaborator

University of Chile

OTHER

Sponsor Role: lead

Responsible Party

Miguel O'Ryan Gallardo

Full Professor, Microbiology and Mycology Department of Medicine Faculty, Universidad de Chile.

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Miguel L O'Ryan, MD

Role: PRINCIPAL_INVESTIGATOR

Microbiology and Micology Program, Faculty of Medicine, University of Chile

Locations

Hospital Van Buren

Valparaíso, Región de Valparaíso, Chile

Hospital Dr Sotero del Rio

Santiago, Santiago Metropolitan, Chile

Countries

Chile

References

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.

Reference Type: BACKGROUND

PMID: 17195704 (View on PubMed)

O'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.

Reference Type: BACKGROUND

PMID: 11465841 (View on PubMed)

Other Identifiers

Merck 2009

Identifier Type: -

Identifier Source: org_study_id