Rotavirus GastroenteritisNCT01508533
Epidemiology of Rotavirus Infection in North India Community
An observational study of Rotavirus Gastroenteritis, run by Society for Applied Studies at 1 site in India.
Trial summary
This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E. Read more about this study
- Who is it for?
- Ages 1 day to 24 monthsHealthy volunteers can take part
- Conditions the study is for
- Rotavirus Gastroenteritis
- How many people
- 200 participants
- Where
- 1 siteIndia
- Study dates
- Jul 2009to Sep 2010
- 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 1 day to 24 months
- All sexes
- Healthy volunteers accepted
- Child
Study population: This study was conducted in Delhi at Govindpuri-Tigri-Dakshinpuri, Tuglakabad and Sangam Vihar.
Who may be able to join
- Parents/guardian consent for participation and are able to understand study procedures
- Healthy infant aged ≤ 1 week - cohort I, children aged 12 months (+14 days)-Cohort 2
- Absence of any illness requiring hospitalization
- No confirmed plans to move in the next 12 months
Who cannot join
- Participating in any other trial
- Any signs or symptoms of active sepsis, pneumonia, meningitis or any other disease requiring hospitalization
- Known case of immunodeficiency disease, known HIV positive
- Known case of chronic gastrointestinal disease
- Any other conditions which in the judgment of the investigator warrant exclusion(e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
Trial locations and contacts
1 site in 1 country.
India1 site
Society for Applied Studies
New Delhi, National Capital Territory of Delhi, 110016
About this study
Official title: Disease Burden Study and Site Preparation for Planning and Implementation of the Phase III Trials for the Oral Rotavirus Vaccine 116E
This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.
Read the detailed description
Field workers conducted weekly surveillance in areas allocated to them and identified pregnant women, newborns and infants aged 9 to 12 months. Children who were eligible for participation through criteria for inclusion and exclusion in the trial were enrolled. Two cohorts were recruited, one cohort enrolled within one week of birth and followed up weekly till 1 year of age (cohort 1=100) and the second cohort enrolled at 12 months of age and followed up till 24 months of age (cohort 2=100).
Weekly contact were made by field workers for both the cohorts. At each contact cases of gastroenteritis were identified. All infants with gastroenteritis were assessed by a field worker/clinical coordinator. The child was assessed for presence of dehydration, danger signs. The field worker/clinical coordinator ensured that at least one diarrheal stool specimen was collected for each episode of gastroenteritis. Infants were treated at the study clinic or escorted to one of the identified hospitals, if required.
Caregivers of the enrolled infants were explained the signs and symptoms of suspected intussusception, dehydration and danger signs that require hospital referral and were given the option to seek care from the study clinic or from one of the identified hospitals in the vicinity.
Stool specimens were collected in all diarrheal episodes. In a subset of 30 children who were identified early in a diarrheal episode and who shed rotavirus, multiple stool specimens were collected in order to assess duration of shedding of rotavirus during a natural infection.
The study was also designed to collect information on data essential for planning and implementation of phase III trials pertaining to trial logistics, data collection tools and validity of questions including those in the Vesikari score.
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- Disease burden, Rotavirus gastroenteritis
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 |
|---|---|---|
| Cohort 1 | Cohort 1: Infants enrolled at ≤1 week and followed up weekly till one year of age. | |
| Cohort 2 | Cohort 2: Infants enrolled at 12 months and followed up weekly till they are aged 24 months. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disease burden
All episodes of gastroenteritis:
- rotavirus gastroenteritis
- rotavirus gastroenteritis by the G and P types
- severe gastroenteritis
- severe rotavirus gastroenteritis
- severity score of all episodes of gastroenteritis
Rates of hospitalization in the above categories
Proportion requiring rehydration therapy in all the above categories
Measured: 1 year
Duration of rotavirus shedding
To ascertain the duration of rotavirus shedding after an episode of rotavirus gastroenteritis
Measured: 1 year
Rotavirus genotypes
To identify genotypes of rotavirus
Measured: 1 year
Data collection for planning and implementation of phase III trials
To collect information on data essential for planning and implementation of phase III trials pertaining to trial logistics, data collection tools and validity of questions including those in the Vesikari score.
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 posted12 Jan 2012 (estimated)
- Study startJul 2009
- Primary completionSep 2009
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rotavirus 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 200 participants (actual)
Sponsor and investigators
- Lead sponsor
- Society for Applied Studies
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Immunology, New Delhi, Ministry of Science and Technology, India
- Responsible party
- Principal investigator, NBhandari, Society for Applied Studies
- Investigators
- Nita Bhandari, PhD, Principal investigator, Society for Applied Studies
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01508533
- Sponsor's protocol ID
- SAS/BBIL/07/2008
- Status last verified
- Jan 2012
- First submitted
- 9 Jan 2012
- Last updated
- 12 Jan 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Disease Burden Study and Site Preparation for Planning and Implementation of the Phase III Trials for the Oral Rotavirus Vaccine 116E
- ClinicalTrials.gov ID
- NCT01508533
- Acronym / sponsor ID
- SAS/BBIL/07/2008
- Conditions
- Rotavirus Gastroenteritis
- Keywords
- Disease burden, Rotavirus gastroenteritis
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Society for Applied StudiesUniversity, hospital or other
- Collaborators
- National Institute of Immunology, New Delhi, Ministry of Science and Technology, India
- Study start
- Jul 2009
- Primary completion
- Sep 2009 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 12 Jan 2012 (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.
This study was designed to support site preparation and to conduct a disease burden study for the planning and implementation of the phase III trials for the oral rotavirus vaccine 116E.
Detailed description
Field workers conducted weekly surveillance in areas allocated to them and identified pregnant women, newborns and infants aged 9 to 12 months. Children who were eligible for participation through criteria for inclusion and exclusion in the trial were enrolled. Two cohorts were recruited, one cohort enrolled within one week of birth and followed up weekly till 1 year of age (cohort 1=100) and the second cohort enrolled at 12 months of age and followed up till 24 months of age (cohort 2=100).
Weekly contact were made by field workers for both the cohorts. At each contact cases of gastroenteritis were identified. All infants with gastroenteritis were assessed by a field worker/clinical coordinator. The child was assessed for presence of dehydration, danger signs. The field worker/clinical coordinator ensured that at least one diarrheal stool specimen was collected for each episode of gastroenteritis. Infants were treated at the study clinic or escorted to one of the identified hospitals, if required.
Caregivers of the enrolled infants were explained the signs and symptoms of suspected intussusception, dehydration and danger signs that require hospital referral and were given the option to seek care from the study clinic or from one of the identified hospitals in the vicinity.
Stool specimens were collected in all diarrheal episodes. In a subset of 30 children who were identified early in a diarrheal episode and who shed rotavirus, multiple stool specimens were collected in order to assess duration of shedding of rotavirus during a natural infection.
The study was also designed to collect information on data essential for planning and implementation of phase III trials pertaining to trial logistics, data collection tools and validity of questions including those in the Vesikari score.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort 1 | – | –Cohort 1: Infants enrolled at ≤1 week and followed up weekly till one year of age. |
| Cohort 2 | – | –Cohort 2: Infants enrolled at 12 months and followed up weekly till they are aged 24 months. |
Who may qualify
- Ages
- 1 day to 24 months
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
- Study population
- This study was conducted in Delhi at Govindpuri-Tigri-Dakshinpuri, Tuglakabad and Sangam Vihar.
Key inclusion criteria (4 listed)
- Parents/guardian consent for participation and are able to understand study procedures
- Healthy infant aged ≤ 1 week - cohort I, children aged 12 months (+14 days)-Cohort 2
- Absence of any illness requiring hospitalization
- No confirmed plans to move in the next 12 months
Key exclusion criteria (5 listed)
- Participating in any other trial
- Any signs or symptoms of active sepsis, pneumonia, meningitis or any other disease requiring hospitalization
- Known case of immunodeficiency disease, known HIV positive
- Known case of chronic gastrointestinal disease
- Any other conditions which in the judgment of the investigator warrant exclusion(e.g. no exclusion criteria but seems 'ill', investigators suspects neglect)
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
Disease burden
Time frame: 1 year
All episodes of gastroenteritis: * rotavirus gastroenteritis * rotavirus gastroenteritis by the G and P types * severe gastroenteritis * severe rotavirus gastroenteritis * severity score of all episodes of gastroenteritis Rates of hospitalization in the above categories Proportion requiring rehydration therapy in all the above categories
Duration of rotavirus shedding
Time frame: 1 year
To ascertain the duration of rotavirus shedding after an episode of rotavirus gastroenteritis
Rotavirus genotypes
Time frame: 1 year
To identify genotypes of rotavirus
Data collection for planning and implementation of phase III trials
Time frame: 1 year
To collect information on data essential for planning and implementation of phase III trials pertaining to trial logistics, data collection tools and validity of questions including those in the Vesikari score.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2012.
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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.
Nita Bhandari, PhD principal investigator
Society for Applied Studies
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 Rotavirus Gastroenteritis, run by Society for Applied Studies at 1 site in India.
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 4 inclusion and 5 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: finished, as of the sponsor's last update on 12 Jan 2012. 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 India. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Disease burden (time frame: 1 year). The study lists 4 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 Jan 2012.