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

NCT01195844 | Terminated Results

• 1 other identifier: V260-031
• Study Type: observational
• Target: 230
• Locations: 0 countries
• Sites: N/A

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

Keywords

Pediatric gastroenteritis, rotavirus infection

Outcome Measures

Primary Outcomes (8)

• 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

Study Arms (1)

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

Interventions

Rotavirus Vaccine 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.

Brazilian Children With Rotavirus Gastroenteritis

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• none specified

Sponsors & Collaborators

• Merck Sharp & Dohme LLC: lead

MeSH Terms

Conditions

Rotavirus Infections

Interventions

Rotavirus Vaccines

Condition Hierarchy (Ancestors)

Reoviridae Infections; RNA Virus Infections; Virus Diseases; Infections

Intervention Hierarchy (Ancestors)

Viral Vaccines; Vaccines; Biological Products; Complex Mixtures

Results Point of Contact

• Title: Senior Vice President, Global Clinical Development
• Organization: Merck Sharp & Dohme Corp

ClinicalTrialsDisclosure@merck.com

1-800-672-6372

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 3, 2010
• First Posted: September 6, 2010
• Study Start: August 1, 2010
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: March 12, 2015
• Results First Posted: December 5, 2012

Record last verified: 2015-02