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

Merck Sharp & Dohme (MSD)

Status: Terminated

Conditions: Pediatric Gastroenteritis

Treatments: Biological: Rotavirus Vaccine

Study type: Observational

Funder types: Industry

Identifiers

NCT01195844

V260-031

Details and patient eligibility

About

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.

Enrollment: 230 patients

Sex: All

Ages: Under 5 years old

Volunteers: No Healthy Volunteers

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

Trial design

230 participants in 1 patient group

Brazilian Children With Rotavirus Gastroenteritis

Description:

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

Treatment:

Biological: Rotavirus Vaccine