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

This study has been terminated.
(Inadequate recruitment)
Sponsor:
Information provided by (Responsible Party):
Merck Sharp & Dohme Corp.
ClinicalTrials.gov Identifier:
NCT01195844
First received: September 3, 2010
Last updated: March 17, 2014
Last verified: March 2014

September 3, 2010
March 17, 2014
August 2010
November 2011   (final data collection date for primary outcome measure)
  • 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.
  • The number of hospitalizations for diarrhea in children under 5 years of age. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The rate of hospitalizations caused by diarrhea in children under 5 years of age. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The distribution of hospitalizations per diarrhea caused by rotavirus. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The percentages of hospitalizations per diarrhea associated to rotavirus at the age groups of 0-3, 3-6, 6-12, 13 -24, 25-36, 37-48 and 49-60 months. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The percentage of hospitalizations associated to diarrhea caused by rotavirus. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The numbers and percentages of hospitalizations for diarrhea and rotavirus-caused diarrhea per month or week. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The average and range of hospitalization duration for hospitalized patients enrolled in the study. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • The number and rate of deaths associated to hospitalized patients enrolled in the study. [ Time Frame: 1 year ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT01195844 on ClinicalTrials.gov Archive Site
Not Provided
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Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
Rotavirus Gastroenteritis in Children Up to 5 Years of Age. Surveillance Performed in Hospitals From Four Brazilian Regions.

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.

Not Provided
Observational
Observational Model: Cohort
Time Perspective: Prospective
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Non-Probability Sample

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

Pediatric Gastroenteritis
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.
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
Intervention: Biological: Rotavirus Vaccine
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
230
November 2011
November 2011   (final data collection date for primary outcome measure)

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
Both
up to 5 Years
No
Contact information is only displayed when the study is recruiting subjects
Not Provided
 
NCT01195844
V260-031
No
Merck Sharp & Dohme Corp.
Merck Sharp & Dohme Corp.
Not Provided
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
Merck Sharp & Dohme Corp.
March 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP