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Inadequate recruitment
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Rotavirus Vaccine | Biological | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age | 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. | 1 year |
| The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age | 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. | 1 year |
| The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by 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. | 1 year |
| The Percentage of Hospitalizations for Diarrhea That Are Caused by 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 divided by the total number of hospitalizations for diarrhea in the 4 hospital research centers. | 1 year |
| The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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Children less than 5 years of age from four Brazilian cities with diarrhea attributed to rotavirus infection.
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| Name | Affiliation | Role |
|---|---|---|
| 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 ClÃnicas da Universidade Federal do Rio de Grande do Sul | Principal Investigator |
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| ID | Title | Description |
|---|---|---|
| FG000 | Children Hospitalized For Diarrhea | Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | Children Who Provided a Fecal Sample | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Customized | Number |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age | 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 population analyzed was all enrolled participants whether or not a fecal sample was obtained | Posted | Number | participants | 1 year |
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1 year
Adverse events were not collected in this observational study
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Children Hospitalized For Diarrhea | Children up to 5 years of age hospitalized for diarrhea in the 4 Brazilian hospital research centers |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Senior Vice President, Global Clinical Development | Merck Sharp & Dohme Corp | 1-800-672-6372 | ClinicalTrialsDisclosure@merck.com |
| ID | Term |
|---|---|
| D012400 | Rotavirus Infections |
| ID | Term |
|---|---|
| D012088 | Reoviridae Infections |
| D012327 | RNA Virus Infections |
| D014777 | Virus Diseases |
| D007239 | Infections |
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| ID | Term |
|---|---|
| D022243 | Rotavirus Vaccines |
| ID | Term |
|---|---|
| D014765 | Viral Vaccines |
| D014612 | Vaccines |
| D001688 | Biological Products |
| D045424 | Complex Mixtures |
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|
| 1 year |
| The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | 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. | 1 year |
| The Duration of Hospitalization for Participants Enrolled in the Study | 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. | From hospital admission to discharge |
| The Number of Deaths in Hospitalized Participants Enrolled in the Study | 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. | 1 year |
| participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Rotavirus Vaccination Received | Number | Participants |
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| Participants |
|
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| Primary | The Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age | 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 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 | Posted | 1 year |
|
|
| Primary | The Geographic Distribution of Hospitalizations for Diarrhea That Are Caused by 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. | 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. | Posted | Number | Participants | 1 year |
|
|
|
| Primary | The Percentage of Hospitalizations for Diarrhea That Are Caused by 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 divided by the total number of hospitalizations for diarrhea in the 4 hospital research centers. | Children hospitalized for diarrhea and providing a fecal sample in the 4 Brazilian hospital research centers | Posted | Number | 95% Confidence Interval | percentage of participants | 1 year |
|
|
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| Primary | The Number of Hospitalizations for Diarrhea That Are Caused by Rotavirus by Age Group | 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 population analyzed was the 27 of 190 participants who had a fecal sample positive for rotavirus. | Posted | Number | participants | 1 year |
|
|
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| Primary | The Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month | 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 population analyzed was all enrolled participants whether or not a fecal sample was obtained | Posted | Number | Participants | 1 year |
|
|
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| Primary | The Duration of Hospitalization for Participants Enrolled in the Study | 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 population analyzed was all enrolled participants whether or not a fecal sample was obtained. | Posted | Mean | Standard Deviation | days | From hospital admission to discharge |
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| Primary | The Number of Deaths in Hospitalized Participants Enrolled in the Study | 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. | Participants were not followed-up in the study; thus the number of deaths was not known. | Posted | 1 year |
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| 0 |
| 0 |
| 0 |
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.
| Title | Measurements |
|---|---|
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| Age 10 to 12 months |
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| Age 13 to 15 months |
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| Age 16 to 18 months |
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| Age 19 to 21 months |
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| Age 22 ato 24 months |
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| Age 25 to 36 months |
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| Age 37 to 48 months |
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| Age >48 months |
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| September 2010 |
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| October 2010 |
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| November 2010 |
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| December 2010 |
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| January 2011 |
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| February 2011 |
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| March 2011 |
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| April 2011 |
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| May 2011 |
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| June 2011 |
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| July 2011 |
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| August 2011 |
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| September 2011 |
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| November 2011 |
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