GastroenteritisNCT01321216
Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
An observational study of Gastroenteritis and Dehydration, run by American University of Beirut Medical Center at 4 sites in Lebanon.
Trial summary
This study aims to determine the contribution of rotavirus infection as a cause of gastroenteritis requiring hospitalization in children younger than 5 years of age. Additionally, a secondary aim will be to determine the genotypes of rotavirus that cause these infections as prevalent in Lebanon. Read more about this study
- Who is it for?
- Ages Up to 5 years
- Conditions the study is for
- Gastroenteritis, Dehydration
- How many people
- 1,555 participants
- Where
- 4 sitesLebanon
- Study dates
- Dec 2011to Jun 2014
- 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 under 5 years of age admitted because of gastroenteritis to 6 major hospitals in Lebanon
Who may be able to join
- Age < 5 years
- Gastroenteritis as admitting diagnosis
- Informed consent
- Parents willing and able to cooperate
Who cannot join
- Age > 5 years
- Onset of gastroenteritis beyond 12 hours of admission
Trial locations and contacts
4 sites in 1 country.
Lebanon4 sites
American University of Beirut
Beirut
Makassed General Hospital
Beirut
Rafik Hariri University Hospital
Beirut
Nini Hospital
Tripoli
About this study
Official title: ESTIMATION OF THE DISEASE BURDEN AND PREVALENT GENOTYPES OF ROTAVIRUS (RV) CAUSING GASTROENTERITIS (GE) IN CHILDREN <5 YEARS OF AGE IN LEBANON BASED ON A SENTINEL HOSPITAL-BASED SURVEILLANCE PROGRAM.
This study aims to determine the contribution of rotavirus infection as a cause of gastroenteritis requiring hospitalization in children younger than 5 years of age. Additionally, a secondary aim will be to determine the genotypes of rotavirus that cause these infections as prevalent in Lebanon.
Read the detailed description
This study will be performed at six large hospitals in Lebanon in the three largest cities Beirut, Tripoli, and Saida. The study will enroll children younger than 5 years of age who are admitted to the hospital because of gastroenteritis. Enrollment will continue for a period of two years at each hospital. Inclusion criteria are age < 5 years, with gastroenteritis as the main reason for admission to the hospital or for a stay in the Emergency Department longer than 12 hours. Exclusion criteria include onset of symptoms beyond 12 hours of admission (health-care associated infection). For all enrolled subjects, data will be collected about severity of illness, outcome, and history of vaccination. Stool samples will be collected for genotyping of rotavirus.
- Conditions
- Gastroenteritis, Dehydration
- Keywords
- rotavirus, gastroenteritis, children, Pediatric, dehydration, vaccine
- Medical subject headings
- Gastroenteritis, Dehydration
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 |
|---|---|---|
| Hospitalized Gastroenteritis | Children under 5 years of age hospitalized with gastroenteritis |
What is being measured
The primary outcome is the main question the study is designed to answer.
Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age
Incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age was 30.3% by PCR
Measured: 2 years
Secondary outcomes (4)
Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program
Measured: 2 years
Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age.
Measured: 2 years
Determining the Age and Seasonal Distribution of RV Associated Hospitalizations in Children < 5 Years of Age
Measured: 2 years
Determining Seasonal Changes and Year-to-year Changes With Respect to Predominant RV Genotypes
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Mar 2011 (estimated)
- Study startDec 2011
- Primary completionJun 2014
- Study completionJun 2014
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 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
- 1,555 participants (actual)
Sponsor and investigators
- Lead sponsor
- American University of Beirut Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Makassed General Hospital, Rafic Hariri University Hospital, Hotel Dieu de France Hospital, Hammoud Hospital University Medical Center, Hopital Nini, Nabatieh Governmental Hospital
- Responsible party
- Principal investigator, Dr. Ghassan Dbaibo, American University of Beirut Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01321216
- Sponsor's protocol ID
- PED.GD.06
- Status last verified
- Feb 2023
- First submitted
- 22 Mar 2011
- Last updated
- 18 Nov 2023
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ESTIMATION OF THE DISEASE BURDEN AND PREVALENT GENOTYPES OF ROTAVIRUS (RV) CAUSING GASTROENTERITIS (GE) IN CHILDREN <5 YEARS OF AGE IN LEBANON BASED ON A SENTINEL HOSPITAL-BASED SURVEILLANCE PROGRAM.
- ClinicalTrials.gov ID
- NCT01321216
- Acronym / sponsor ID
- PED.GD.06
- Conditions
- Gastroenteritis, Dehydration
- Keywords
- rotavirus, gastroenteritis, children, Pediatric, dehydration, vaccine
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,555 participants (actual)
- Lead sponsor
- American University of Beirut Medical CenterUniversity, hospital or other
- Collaborators
- Makassed General Hospital, Rafic Hariri University Hospital, Hotel Dieu de France Hospital, Hammoud Hospital University Medical Center, Hopital Nini, Nabatieh Governmental Hospital
- Study start
- Dec 2011 (actual)
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 23 Mar 2011 (estimated)
- Results
- Posted 18 Nov 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study aims to determine the contribution of rotavirus infection as a cause of gastroenteritis requiring hospitalization in children younger than 5 years of age. Additionally, a secondary aim will be to determine the genotypes of rotavirus that cause these infections as prevalent in Lebanon.
Detailed description
This study will be performed at six large hospitals in Lebanon in the three largest cities Beirut, Tripoli, and Saida. The study will enroll children younger than 5 years of age who are admitted to the hospital because of gastroenteritis. Enrollment will continue for a period of two years at each hospital. Inclusion criteria are age < 5 years, with gastroenteritis as the main reason for admission to the hospital or for a stay in the Emergency Department longer than 12 hours. Exclusion criteria include onset of symptoms beyond 12 hours of admission (health-care associated infection). For all enrolled subjects, data will be collected about severity of illness, outcome, and history of vaccination. Stool samples will be collected for genotyping of rotavirus.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Hospitalized Gastroenteritis | – | –Children under 5 years of age hospitalized with gastroenteritis |
Who may qualify
- Ages
- Up to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
- Study population
- Children under 5 years of age admitted because of gastroenteritis to 6 major hospitals in Lebanon
Key inclusion criteria (4 listed)
- Age < 5 years
- Gastroenteritis as admitting diagnosis
- Informed consent
- Parents willing and able to cooperate
Key exclusion criteria (2 listed)
- Age > 5 years
- Onset of gastroenteritis beyond 12 hours of admission
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
Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age
Time frame: 2 years
Incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age was 30.3% by PCR
4 secondary outcomes
Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program
Time frame: 2 years
Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age.
Time frame: 2 years
Determining the Age and Seasonal Distribution of RV Associated Hospitalizations in Children < 5 Years of Age
Time frame: 2 years
Determining Seasonal Changes and Year-to-year Changes With Respect to Predominant RV Genotypes
Time frame: 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Nov 2023.
- 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.
The record lists no contact. Use the official record to reach the sponsor.
4 sites 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 Dehydration, run by American University of Beirut Medical Center at 4 sites in Lebanon.
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 2 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 18 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Lebanon. 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?
Yes. Results are posted in the registry (first posted 18 Nov 2023). 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?
Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age (time frame: 2 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 18 Nov 2023.