Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).

NCT ID: NCT01195844

Last Updated: 2015-03-12

Basic Information

• Recruitment Status: TERMINATED
• Total Enrollment: 230 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2010-08-31
• Study Completion Date: 2011-11-30

Brief Summary

This is a 1-year study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children < 5 years of age, conducted in four hospitals located in four Brazilian regions. A stool sample from each eligible child passing 3 or more loose stools or watery stools within a period of 24 hours and requiring hospitalization or rehydration therapy (oral or IV rehydration) will be tested for the presence of rotavirus, using standard laboratory procedures (ie, Enzyme Linked Ligand Sorbent Assay, or ELlSA) by all participating hospitals.

Conditions

Pediatric Gastroenteritis

Study Design

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

Study Groups

Brazilian Children With Rotavirus Gastroenteritis

Brazilian children under 5 years of age who have diarrhea attributed to rotavirus located in 4 hospitals from 4 different Brazilian regions

Rotavirus Vaccine

Intervention Type: BIOLOGICAL

This is an observational study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children \< 5 years of age; however, any rotavirus vaccines used in the children presenting with rotavirus-attributed diarrhea were evaluated, as well the prevalent rotavirus serotypes in this sample for future vaccine development.

Interventions

Rotavirus Vaccine

This is an observational study evaluating hospitalizations and the medical care for the treatment of diarrhea from rotavirus infection in children \< 5 years of age; however, any rotavirus vaccines used in the children presenting with rotavirus-attributed diarrhea were evaluated, as well the prevalent rotavirus serotypes in this sample for future vaccine development.

Intervention Type: BIOLOGICAL

Eligibility Criteria

Inclusion Criteria

• a child < 5 years of age being treated for acute gastroenteritis within 72 hours prior to evaluation in the study hospitals.
• outpatient children < 5 years of age submitted for treatment of acute gastroenteritis within 72 hours prior to evaluation in the study clinics.

Exclusion Criteria

• none specified

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

Sponsors

Merck Sharp & Dohme LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Divina das Dores P Cardoso, Doctor

Role: PRINCIPAL_INVESTIGATOR

Instituto de Patologia Tropical e Saúde Pública IPTSP-UFG

Edson Moreira, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Hospital Santo Antonio - Obras Sociais Irma Dulce

Alfredo Gilio, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital Universitário da Universidade de Sao Paulo

Paulo Carvalho, MD

Role: PRINCIPAL_INVESTIGATOR

Hospital de Clínicas da Universidade Federal do Rio de Grande do Sul

Other Identifiers

V260-031

Identifier Type: -

Identifier Source: org_study_id