GastroenteritisNCT01363726
Surveillance of Rotavirus Gastroenteritis in Children <5 Years
An observational study of Gastroenteritis and Rotavirus Infections, run by Soroka University Medical Center at 1 site in Israel.
Trial summary
The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Gastroenteritis, Rotavirus Infections
- How many people
- 30,000 participants
- Where
- 1 siteIsrael
- Study dates
- Oct 2005to not given
- Phase
- Observational
- Are there results?
- None posted in the registry
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: Survieillance of Rotavirus Gastroenteritis Among Children Bedouin and Jewish < 5 years with gastro enteritis visiting the ER in southern Israel
Who may be able to join
- Children < 5 years with
- Gastro enteritis
- Visiting the ER
- Residents of southern Israel
- Signed informed concent -
Who cannot join
- Not all of the above
Trial locations and contacts
1 site in 1 country.
Israel1 site, 1 recruiting
- Recruiting
Pediatric infectious disease unit Soroka U medical center
Beersheba, 84101
David Greenberg, MD, 97286400547, dudi@bgu.ac.il
Oshrit Sabach, 97286400547, sabacho@bgu.ac.il
About this study
Official title: Surveillance of Rotavirus Gastroenteritis Among Children <5 Years of Age Visiting the Pediatric Emergency Room in Southern Israel
The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.
Read the detailed description
Monitoring of diarrheal disease and observe changes after the introduction of the rota vaccine Comparing the epidemiology in Jewish and Bedouin population before and after the introduction of the rota vaccine into the national immunization program
- Conditions
- Gastroenteritis, Rotavirus Infections
- Keywords
- surveillance Rotavirus Gastroenteritis Children, < 5 years of age, southern Israel, Signed informed concent
- Medical subject headings
- Gastroenteritis, Rotavirus Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 2 | Jewish and Bedouin children < 5 years of age in southern Israel |
What is being measured
The primary outcome is the main question the study is designed to answer.
epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction
To assess the proportion of rotavirus gastroenteritis among children <5 years of age visiting the pediatric ER in southern Israel. To assess the hospitalization rate due to rotavirus.
Measured: 7 years
Secondary outcomes (1)
To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations.
To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations.
Measured: 7 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2011 (estimated)
- Study startOct 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GastroenteritisStudies of the same condition, open and under way.
- 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
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 30,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Soroka University Medical Center
- Sponsor type
- University, hospital or other
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01363726
- Sponsor's protocol ID
- sor415005ctil
- Status last verified
- Oct 2005
- First submitted
- 30 May 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Surveillance of Rotavirus Gastroenteritis Among Children <5 Years of Age Visiting the Pediatric Emergency Room in Southern Israel
- ClinicalTrials.gov ID
- NCT01363726
- Acronym / sponsor ID
- sor415005ctil
- Conditions
- Gastroenteritis, Rotavirus Infections
- Keywords
- surveillance Rotavirus Gastroenteritis Children, < 5 years of age, southern Israel, Signed informed concent
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 30,000 participants (estimated)
- Lead sponsor
- Soroka University Medical CenterUniversity, hospital or other
- Study start
- Oct 2005
- First posted
- 1 Jun 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to monitor diarrheal disease and observe changes after the introduction of the rota vaccine.
Detailed description
Monitoring of diarrheal disease and observe changes after the introduction of the rota vaccine Comparing the epidemiology in Jewish and Bedouin population before and after the introduction of the rota vaccine into the national immunization program
Study design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 2 | – | –Jewish and Bedouin children < 5 years of age in southern Israel |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Survieillance of Rotavirus Gastroenteritis Among Children Bedouin and Jewish < 5 years with gastro enteritis visiting the ER in southern Israel
Key inclusion criteria (5 listed)
- Children < 5 years with
- Gastro enteritis
- Visiting the ER
- Residents of southern Israel
- Signed informed concent -
Key exclusion criteria (1 listed)
- Not all of the above
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction
Time frame: 7 years
To assess the proportion of rotavirus gastroenteritis among children <5 years of age visiting the pediatric ER in southern Israel. To assess the hospitalization rate due to rotavirus.
1 secondary outcome
To compare rotavirus gastroenteritis among children <5 years of age from Jewish and Bedouin populations.
Time frame: 7 years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jun 2011.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gastroenteritis and Rotavirus Infections, run by Soroka University Medical Center at 1 site in Israel.
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 5 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: status not confirmed, as of the sponsor's last update on 1 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Israel. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
epidemiology of rota virus disease in southern Israel before and after the rota virus vaccine introduction (time frame: 7 years). 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 1 Jun 2011.