Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2013 by American University of Beirut Medical Center.
Recruitment status was Recruiting
Recruitment status was Recruiting
Sponsor:
American University of Beirut Medical Center
Collaborators:
Makassed General Hospital
Rafic Hariri University Hospital
Hotel Dieu de France Hospital
Hammoud Hospital
Nini Hospital
Nabatieh Governmental Hospital
Information provided by (Responsible Party):
Dr. Ghassan Dbaibo, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01321216
First received: March 22, 2011
Last updated: January 31, 2013
Last verified: January 2013
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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 |
|---|
|
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. |
Resource links provided by NLM:
Further study details as provided by American University of Beirut Medical Center:
Primary Outcome Measures:
- Estimating the incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 |
|---|
|
Hospitalized Gastroenteritis
Children under 5 years of age hospitalized with gastroenteritis
|
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 (Child) |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
Study Population
Children under 5 years of age admitted because of gastroenteritis to 6 major hospitals in Lebanon
Criteria
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
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321216
Please refer to this study by its ClinicalTrials.gov identifier: NCT01321216
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 | |
Sponsors and Collaborators
American University of Beirut Medical Center
Makassed General Hospital
Rafic Hariri University Hospital
Hotel Dieu de France Hospital
Hammoud Hospital
Nini Hospital
Nabatieh Governmental Hospital
More Information
| 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:
|
Gastroenteritis Dehydration Gastrointestinal Diseases Digestive System Diseases |
Water-Electrolyte Imbalance Metabolic Diseases Pathologic Processes |
ClinicalTrials.gov processed this record on September 30, 2016