Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
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Purpose
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.
| Condition |
|---|
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Gastroenteritis Dehydration |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| 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. |
- Estimating the incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Identifying the most prevalent RV genotypes in the target population included in the surveillance program [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Estimating the proportion of diarrheal hospitalization due to RV in children < 5 years of age. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Determining the age and seasonal distribution of RV associated hospitalizations in children < 5 years of age [ Time Frame: 2 years ] [ Designated as safety issue: No ]
- Determining seasonal changes and year-to-year changes with respect to predominant RV genotypes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Biospecimen Retention: Samples With DNA
Stool samples with rotavirus RNA
| Estimated Enrollment: | 1600 |
| Study Start Date: | January 2011 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | January 2013 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Hospitalized Gastroenteritis
Children under 5 years of age hospitalized with gastroenteritis
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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.
Eligibility| Ages Eligible for Study: | up to 5 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Children under 5 years of age admitted because of gastroenteritis to 6 major hospitals in Lebanon
Inclusion Criteria:
- Age < 5 years
- Gastroenteritis as admitting diagnosis
- Informed consent
- Parents willing and able to cooperate
Exclusion Criteria:
- Age > 5 years
- Onset of gastroenteritis beyond 12 hours of admission
Contacts and Locations| Lebanon | |
| American University of Beirut | Recruiting |
| Beirut, Lebanon | |
| Contact: Ghassan Dbaibo, MD +9611374374 ext 5752 gdbaibo@aub.edu.lb | |
| Contact: Carelle Tabet, RN, MSN +9611374374 ext 5752 ct04@aub.edu.lb | |
| Principal Investigator: Ghassan Dbaibo, MD | |
| Makassed General Hospital | Recruiting |
| Beirut, Lebanon | |
| Contact: Mariam Rajab, MD +9613301846 drmariam1@hotmail.com | |
| Principal Investigator: Mariam Rajab, MD | |
| Rafik Hariri University Hospital | Recruiting |
| Beirut, Lebanon | |
| Contact: Hassan Fakhouri, MD +9613204259 drhassanf@yahoo.com | |
| Principal Investigator: Hassan Fakhouri, MD | |
| Nini Hospital | Recruiting |
| Tripoli, Lebanon | |
| Contact: Adlette Inati, MD +9613228033 adlette.inati@lau.edu.lb | |
| Principal Investigator: Adlette Inati, MD | |
More Information
No publications provided
| Responsible Party: | Dr. Ghassan Dbaibo, Pediatrician Doctor, American University of Beirut Medical Center |
| ClinicalTrials.gov Identifier: | NCT01321216 History of Changes |
| Other Study ID Numbers: | PED.GD.06 |
| Study First Received: | March 22, 2011 |
| Last Updated: | January 31, 2013 |
| Health Authority: | Lebanon: Institutional Review Board |
Keywords provided by American University of Beirut Medical Center:
|
rotavirus gastroenteritis children |
Pediatric dehydration vaccine |
Additional relevant MeSH terms:
|
Dehydration Gastroenteritis Water-Electrolyte Imbalance Metabolic Diseases |
Pathologic Processes Gastrointestinal Diseases Digestive System Diseases |
ClinicalTrials.gov processed this record on May 16, 2013