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

Terminated

• Conditions: Pediatric Gastroenteritis
• Interventions: Biological: Rotavirus Vaccine

• Registration Number: NCT01195844
• Lead Sponsor: Merck Sharp & Dohme LLC

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-08
• Study First Submitted: 2010-09-03
• Study First Submitted QC: 2010-09-03
• Study First Posted: 2010-09-06
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Results First Submitted: 2012-11-08
• Results First Submitted QC: 2012-11-08
• Results First Posted: 2012-12-05
• Status Verified: 2015-02
• Last Update Submitted: 2015-02-23
• Last Update Posted: 2015-03-12

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 230

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Brazilian Children With Rotavirus Gastroenteritis	Rotavirus Vaccine	Brazilian children under 5 years of age who have diarrhea attributed to rotavirus located in 4 hospitals from 4 different Brazilian regions

Primary Outcome Measures

Name	Time	Method
The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age	1 year	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.
The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus	1 year	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.
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group	1 year	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.
The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus	1 year	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.
The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age	1 year	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.
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month	1 year	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 Duration of Hospitalization for Participants Enrolled in the Study	From hospital admission to discharge	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.
The Number of Deaths in Hospitalized Participants Enrolled in the Study	1 year	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.