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临床试验/NCT01195844
NCT01195844终止不适用

Rotavirus Gastroenteritis in Children Up to 5 Years of Age. Surveillance Performed in Hospitals From Four Brazilian Regions.

Merck Sharp & Dohme LLC0 个研究点目标入组 230 人开始时间: 2010年8月最近更新:
适应症

试验速览

阶段
不适用
状态
终止
入组人数
230
主要终点
The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age

研究概览

简要总结

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.

研究设计

研究类型
Observational
观察模型
Cohort
时间视角
Prospective

入排标准

年龄范围
— 至 5 Years(Child)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • none specified

结局指标

主要结局

The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age

时间窗: 1 year

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

时间窗: 1 year

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 Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group

时间窗: 1 year

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 Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus

时间窗: 1 year

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 in Children up to 5 Years of Age

时间窗: 1 year

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 Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month

时间窗: 1 year

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

时间窗: From hospital admission to discharge

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

时间窗: 1 year

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.

次要结局

未报告次要终点

研究者

申办方类型
Industry
责任方
Sponsor

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