Clinical trial NCT01195844: Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
Official title: Rotavirus Gastroenteritis in Children Up to 5 Years of Age. Surveillance Performed in Hospitals From Four Brazilian Regions.
Study type: OBSERVATIONAL
Overall status: TERMINATED
Conditions: Pediatric Gastroenteritis
Keywords: Pediatric gastroenteritis, rotavirus infection
Lead sponsor: Merck Sharp & Dohme LLC
Sponsor class: INDUSTRY
First posted: 2010-09-06
Enrollment: 230
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children less than 5 years of age from four Brazilian cities with diarrhea attributed to rotavirus infection.

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.


Eligibility 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

Primary outcomes:
measure: The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age
timeFrame: 1 year
measure: The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age
timeFrame: 1 year
measure: The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus
timeFrame: 1 year
measure: The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus
timeFrame: 1 year
measure: The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
timeFrame: 1 year
measure: The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
timeFrame: 1 year
measure: The Duration of Hospitalization for Participants Enrolled in the Study
timeFrame: From hospital admission to discharge
measure: The Number of Deaths in Hospitalized Participants Enrolled in the Study
timeFrame: 1 year
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
affiliation: Instituto de Patologia Tropical e Saúde Pública IPTSP-UFG
name: Divina das Dores P Cardoso, Doctor
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Santo Antonio - Obras Sociais Irma Dulce
name: Edson Moreira, MD, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital Universitário da Universidade de Sao Paulo
name: Alfredo Gilio, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hospital de Clínicas da Universidade Federal do Rio de Grande do Sul
name: Paulo Carvalho, MD
role: PRINCIPAL_INVESTIGATOR
References: