Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031 AM1). - Full Text View

Purpose

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.

Condition	Intervention
Pediatric Gastroenteritis	Biological: Rotavirus Vaccine

Study Type:	Observational
Study Design:	Observational Model: Cohort Time Perspective: Prospective
Official Title:	Rotavirus Gastroenteritis in Children Up to 5 Years of Age. Surveillance Performed in Hospitals From Four Brazilian Regions.

Resource links provided by NLM:

MedlinePlus related topics: Diarrhea Gastroenteritis Rotavirus Infections

Drug Information available for: Rotarix

U.S. FDA Resources

Further study details as provided by Merck:

Primary Outcome Measures:

The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 That Are Caused by Rotavirus by Age Group [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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 [ Time Frame: From hospital admission to discharge ] [ Designated as safety issue: No ]
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 [ Time Frame: 1 year ] [ Designated as safety issue: No ]
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.

Enrollment:	230
Study Start Date:	August 2010
Study Completion Date:	November 2011
Primary Completion Date:	November 2011 (Final data collection date for primary outcome measure)

Groups/Cohorts	Assigned Interventions
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.

Eligibility

Ages Eligible for Study:	up to 5 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No
Sampling Method:	Non-Probability Sample

Study Population

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

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01195844

Sponsors and Collaborators

Merck

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

More Information

No publications provided

Responsible Party:	Merck
ClinicalTrials.gov Identifier:	NCT01195844 History of Changes
Other Study ID Numbers:	V260-031
Study First Received:	September 3, 2010
Results First Received:	November 8, 2012
Last Updated:	January 2, 2013
Health Authority:	Brazil: Ethics Committee

Keywords provided by Merck:

Pediatric gastroenteritis, rotavirus infection

Additional relevant MeSH terms:

Gastroenteritis
Rotavirus Infections
Gastrointestinal Diseases
Digestive System Diseases

Reoviridae Infections
RNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on May 19, 2013