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

Rotavirus Gastroenteritis in Children Up to 5 Years of Age. Surveillance Performed in Hospitals From Four Brazilian Regions.

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.

Study Overview

• Status: Terminated
• Conditions: Pediatric Gastroenteritis
• Intervention / Treatment: Biological: Rotavirus Vaccine

• Study Type: Observational
• Enrollment (Actual): 230

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Children less than 5 years of age from four Brazilian cities with diarrhea attributed to rotavirus infection.

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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	Biological: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age	The total number of hospitalizations for diarrhea in children up to 5 years of age in the 4 Brazilian hospital research centers was reported. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.	1 year
The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age	The percentage of total hospitalizations for children up to 5 years of age in the 4 Brazilian hospital research centers that were for diarrhea. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.	1 year
The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus	Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. For each geographic location, the number of hospitalizations for diarrhea that was caused by rotavirus was reported.	1 year
The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus	Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was divided by the total number of hospitalizations for diarrhea in the 4 hospital research centers.	1 year
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group	Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period. The number of hospitalizations for diarrhea from rotavirus infection was reported for each age group.	1 year
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month	Children up to 5 years of age hospitalized for diarrhea were tested for fecal rotavirus as determined by enzyme immunoassay. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.	1 year
The Duration of Hospitalization for Participants Enrolled in the Study	The mean duration (days) of hospital stay for children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.	From hospital admission to discharge
The Number of Deaths in Hospitalized Participants Enrolled in the Study	The number of deaths among children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers. Diarrhea was defined as the passage of 3 or more soft/liquid feces in a 24-hour period.	1 year

Collaborators and Investigators

• Sponsor: Merck Sharp & Dohme LLC
• Investigators: Principal Investigator: Divina das Dores P Cardoso, Doctor, Instituto de Patologia Tropical e Saúde Pública IPTSP-UFG; Principal Investigator: Edson Moreira, MD, PhD, Hospital Santo Antonio - Obras Sociais Irma Dulce; Principal Investigator: Alfredo Gilio, MD, Hospital Universitário da Universidade de Sao Paulo; Principal Investigator: Paulo Carvalho, MD, Hospital de Clínicas da Universidade Federal do Rio de Grande do Sul

Study record dates

Study Major Dates

• Study Start: August 1, 2010
• Primary Completion (Actual): November 1, 2011
• Study Completion (Actual): November 1, 2011

Study Registration Dates

• First Submitted: September 3, 2010
• First Submitted That Met QC Criteria: September 3, 2010
• First Posted (Estimate): September 6, 2010

Study Record Updates

• Last Update Posted (Estimate): March 12, 2015
• Last Update Submitted That Met QC Criteria: February 23, 2015
• Last Verified: February 1, 2015

More Information

Terms related to this study

• Keywords: Pediatric gastroenteritis, rotavirus infection
• Additional Relevant MeSH Terms: Digestive System Diseases; RNA Virus Infections; Virus Diseases; Infections; Gastrointestinal Diseases; Reoviridae Infections; Gastroenteritis; Rotavirus Infections
• Other Study ID Numbers: V260-031