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

NCT01195844 · Status: TERMINATED · Type: OBSERVATIONAL · Enrollment: 230

Last updated 2015-03-12

Study results available
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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

Interventions

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.

Sponsors & Collaborators

Principal Investigators

  • Divina das Dores P Cardoso, Doctor · Instituto de Patologia Tropical e Saúde Pública IPTSP-UFG

  • Edson Moreira, MD, PhD · Hospital Santo Antonio - Obras Sociais Irma Dulce

  • Alfredo Gilio, MD · Hospital Universitário da Universidade de Sao Paulo

  • Paulo Carvalho, MD · Hospital de Clínicas da Universidade Federal do Rio de Grande do Sul

Eligibility

Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2010-08-31
Primary Completion
2011-11-30
Completion
2011-11-30

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT01195844 on ClinicalTrials.gov