Pediatric GastroenteritisNCT01195844
Gastroenteritis From Rotavirus Infection in Brazilian Children Less Than 5 Years of Age (Study V260-031).
An observational study of Pediatric Gastroenteritis, run by Merck Sharp & Dohme LLC.
Trial 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. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Pediatric Gastroenteritis
- What is being tested?
- Rotavirus Vaccine
- Type of treatment
- Vaccines
- How many people
- 230 participants
- Where
- No sites listed yet
- Study dates
- Aug 2010to Nov 2011
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 5 years
- All sexes
- No healthy volunteers
- Child
Study population: Children less than 5 years of age from four Brazilian cities with diarrhea attributed to rotavirus infection.
Who may be able to join
- 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.
Who cannot join
- none specified
About this study
Official title: 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.
- Conditions
- Pediatric Gastroenteritis
- Being tested
- Rotavirus Vaccine
- Keywords
- Pediatric gastroenteritis, rotavirus infection
- Medical subject headings
- Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rotavirus VaccineBiological
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Biological: Rotavirus Vaccine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Sep 2010 (estimated)
- Study startAug 2010
- Primary completionNov 2011
- Study completionNov 2011
Why it stopped: Inadequate recruitment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Pediatric GastroenteritisStudies of the same condition, open and under way.
- More trials run by Merck Sharp & Dohme LLCThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Merck Sharp & Dohme LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Divina das Dores P Cardoso, Doctor, Principal investigator, Instituto de Patologia Tropical e Saúde Pública IPTSP-UFGEdson Moreira, MD, PhD, Principal investigator, Hospital Santo Antonio - Obras Sociais Irma DulceAlfredo Gilio, MD, Principal investigator, Hospital Universitário da Universidade de Sao PauloPaulo Carvalho, MD, Principal investigator, Hospital de Clínicas da Universidade Federal do Rio de Grande do Sul
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01195844
- Sponsor's protocol ID
- V260-031
- Status last verified
- Feb 2015
- First submitted
- 3 Sep 2010
- Last updated
- 12 Mar 2015
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Rotavirus Gastroenteritis in Children Up to 5 Years of Age. Surveillance Performed in Hospitals From Four Brazilian Regions.
- ClinicalTrials.gov ID
- NCT01195844
- Acronym / sponsor ID
- V260-031
- Conditions
- Pediatric Gastroenteritis
- Keywords
- Pediatric gastroenteritis, rotavirus infection
- Study type
- Observational
- Recruitment status
- TerminatedReason stopped: Inadequate recruitment
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Merck Sharp & Dohme LLCIndustry (pharma, biotech, devices)
- Study start
- Aug 2010
- Primary completion
- Nov 2011 (actual)
- Study completion
- Nov 2011 (actual)
- First posted
- 6 Sep 2010 (estimated)
- Results
- Posted 5 Dec 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Brazilian Children With Rotavirus Gastroenteritis | – | Biological: Rotavirus VaccineBrazilian children under 5 years of age who have diarrhea attributed to rotavirus located in 4 hospitals from 4 different Brazilian regions |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children less than 5 years of age from four Brazilian cities with diarrhea attributed to rotavirus infection.
Key inclusion criteria (2 listed)
- 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.
Key exclusion criteria (1 listed)
- none specified
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Rotavirus VaccineThis 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. | Biological | Brazilian Children With Rotavirus Gastroenteritis |
Primary outcome
The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age
Time frame: 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 Percentage of Hospitalizations for Diarrhea in Children up to 5 Years of Age
Time frame: 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
Time frame: 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 Percentage of Hospitalizations for Diarrhea That Are Caused by Rotavirus
Time frame: 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 That Are Caused by Rotavirus by Age Group
Time frame: 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 Numbers of Participants Hospitalized for Diarrhea and Rotavirus-caused Diarrhea Per Month
Time frame: 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
Time frame: 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
Time frame: 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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Mar 2015.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Divina das Dores P Cardoso, Doctor principal investigator
Instituto de Patologia Tropical e Saúde Pública IPTSP-UFG
Edson Moreira, MD, PhD principal investigator
Hospital Santo Antonio - Obras Sociais Irma Dulce
Alfredo Gilio, MD principal investigator
Hospital Universitário da Universidade de Sao Paulo
Questions about this trial
What is this clinical trial studying?
An observational study of Pediatric Gastroenteritis, run by Merck Sharp & Dohme LLC.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 12 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Dec 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The Number of Hospitalizations for Diarrhea in Children up to 5 Years of Age (time frame: 1 year). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Mar 2015.