Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
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ClinicalTrials.gov Identifier: NCT01321216 |
Recruitment Status
: Unknown
Verified January 2013 by Dr. Ghassan Dbaibo, American University of Beirut Medical Center.
Recruitment status was: Recruiting
First Posted
: March 23, 2011
Last Update Posted
: February 1, 2013
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Condition or disease |
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Gastroenteritis Dehydration |
Study Type : | Observational |
Estimated Enrollment : | 1600 participants |
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. |
Study Start Date : | January 2011 |
Estimated Primary Completion Date : | January 2013 |
Estimated Study Completion Date : | June 2013 |
Group/Cohort |
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Hospitalized Gastroenteritis
Children under 5 years of age hospitalized with gastroenteritis
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- Estimating the incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age [ Time Frame: 2 years ]
- 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 ]
Biospecimen Retention: Samples With DNA

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Ages Eligible for Study: | up to 5 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Sampling Method: | Non-Probability Sample |
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

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321216
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 |
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 |
First Posted: | March 23, 2011 Key Record Dates |
Last Update Posted: | February 1, 2013 |
Last Verified: | January 2013 |
Keywords provided by Dr. Ghassan Dbaibo, American University of Beirut Medical Center:
rotavirus gastroenteritis children |
Pediatric dehydration vaccine |
Additional relevant MeSH terms:
Gastroenteritis Dehydration Gastrointestinal Diseases Digestive System Diseases |
Water-Electrolyte Imbalance Metabolic Diseases Pathologic Processes |