Trial Outcomes & Findings for Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031). (NCT NCT01195844)
NCT ID: NCT01195844
Last Updated: 2015-03-12
Results Overview
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.
TERMINATED
230 participants
1 year
2015-03-12
Participant Flow
Participant milestones
| Measure |
Children Hospitalized For Diarrhea
Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
|
|---|---|
|
Overall Study
STARTED
|
230
|
|
Overall Study
COMPLETED
|
190
|
|
Overall Study
NOT COMPLETED
|
40
|
Reasons for withdrawal
| Measure |
Children Hospitalized For Diarrhea
Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers
|
|---|---|
|
Overall Study
Fecal sample not collected
|
40
|
Baseline Characteristics
Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
Baseline characteristics by cohort
| Measure |
Children Who Provided a Fecal Sample
n=190 Participants
Children up to 5 years of age hospitalized for diarrhea and providing a fecal sample 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.
|
|---|---|
|
Age, Customized
|
190 participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
84 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
106 Participants
n=5 Participants
|
|
Rotavirus Vaccination Received
Yes
|
175 Participants
n=5 Participants
|
|
Rotavirus Vaccination Received
No
|
15 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The population analyzed was all enrolled participants whether or not a fecal sample was obtained
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.
Outcome measures
| Measure |
Children Hospitalized For Diarrhea
n=230 Participants
Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
|
Goiânia (Center-West)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
|
Porto Alegre (South)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
|
São Paulo (Southeast)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
|
|---|---|---|---|---|
|
The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age
|
230 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The population to be analyzed was all hospitalizations for any reason for children up to 5 years of age in the 4 hospital research centers The number of total hospitalizations for children up to 5 years of age was not known; thus this outcome measure was not evaluated
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.
Outcome measures
Outcome data not reported
PRIMARY outcome
Timeframe: 1 yearPopulation: The population analyzed was children up to 5 years of age hospitalized for diarrhea. A total of 190 of the 230 participants had fecal samples analyzed; 27 of these had stool samples positive for 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.
Outcome measures
| Measure |
Children Hospitalized For Diarrhea
n=55 Participants
Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
|
Goiânia (Center-West)
n=101 Participants
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
|
Porto Alegre (South)
n=8 Participants
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
|
São Paulo (Southeast)
n=26 Participants
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
|
|---|---|---|---|---|
|
The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by Rotavirus
|
17 Participants
|
3 Participants
|
0 Participants
|
7 Participants
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Children hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers
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.
Outcome measures
| Measure |
Children Hospitalized For Diarrhea
n=190 Participants
Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
|
Goiânia (Center-West)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
|
Porto Alegre (South)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
|
São Paulo (Southeast)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
|
|---|---|---|---|---|
|
The Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus
|
14.2 percentage of participants
Interval 12.49 to 15.93
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The population analyzed was the 27 of 190 participants who had a fecal sample positive for 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 reported for each age group.
Outcome measures
| Measure |
Children Hospitalized For Diarrhea
n=27 Participants
Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
|
Goiânia (Center-West)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
|
Porto Alegre (South)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
|
São Paulo (Southeast)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
|
|---|---|---|---|---|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 0 to 3 months
|
2 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 4 to 6 months
|
0 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 7 to 9 months
|
0 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 10 to 12 months
|
1 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 13 to 15 months
|
3 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 16 to 18 months
|
2 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 19 to 21 months
|
1 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 22 ato 24 months
|
3 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 25 to 36 months
|
8 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age 37 to 48 months
|
3 participants
|
—
|
—
|
—
|
|
The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group
Age >48 months
|
4 participants
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: The population analyzed was all enrolled participants whether or not a fecal sample was obtained
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.
Outcome measures
| Measure |
Children Hospitalized For Diarrhea
n=230 Participants
Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
|
Goiânia (Center-West)
n=27 Participants
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
|
Porto Alegre (South)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
|
São Paulo (Southeast)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
|
|---|---|---|---|---|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
January 2010
|
1 Participants
|
0 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
August 2010
|
41 Participants
|
5 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
September 2010
|
24 Participants
|
8 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
October 2010
|
7 Participants
|
2 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
November 2010
|
23 Participants
|
0 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
December 2010
|
7 Participants
|
0 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
January 2011
|
5 Participants
|
0 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
February 2011
|
14 Participants
|
1 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
March 2011
|
6 Participants
|
0 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
April 2011
|
12 Participants
|
2 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
May 2011
|
18 Participants
|
0 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
June 2011
|
16 Participants
|
2 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
July 2011
|
22 Participants
|
2 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
August 2011
|
18 Participants
|
4 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
September 2011
|
13 Participants
|
1 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
October 2011
|
2 Participants
|
0 Participants
|
—
|
—
|
|
The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
November 2011
|
1 Participants
|
0 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: From hospital admission to dischargePopulation: The population analyzed was all enrolled participants whether or not a fecal sample was obtained.
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.
Outcome measures
| Measure |
Children Hospitalized For Diarrhea
n=230 Participants
Children hospitalized for diarrhea in the 4 Brazilian hospital research centers
|
Goiânia (Center-West)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Goiânia (Center-West Brazil) hospital research center
|
Porto Alegre (South)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the Porto Alegre (South Brazil) hospital research center
|
São Paulo (Southeast)
Children up to 5 years of age hospitalized for diarrhea that tested positive for rotavirus in the São Paulo (Southeast Brazil) hospital research center
|
|---|---|---|---|---|
|
The Duration of Hospitalization for Participants Enrolled in the Study
|
1.83 days
Standard Deviation 2.65
|
—
|
—
|
—
|
PRIMARY outcome
Timeframe: 1 yearPopulation: Participants were not followed-up in the study; thus the number of deaths was not known.
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.
Outcome measures
Outcome data not reported
Adverse Events
Children Hospitalized For Diarrhea
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Senior Vice President, Global Clinical Development
Merck Sharp & Dohme Corp
Results disclosure agreements
- Principal investigator is a sponsor employee The initial publication of this study will be multicenter, comprising data from all sites involved. After the multicenter publication, or 24 months after the end of the study, each site involved may publish its own results in an independent fashion. The sponsor will also have the opportunity to review all the proposed abstracts, manuscripts or lectures related to this study 60 days before submission for publication/presentation.
- Publication restrictions are in place
Restriction type: OTHER