Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon

This study is currently recruiting participants.

Verified January 2013 by American University of Beirut Medical Center

Sponsor:

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

History of Changes

Tracking Information
First Received Date ^ICMJE	March 22, 2011
Last Updated Date	January 31, 2013
Start Date ^ICMJE	January 2011
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: March 22, 2011)	Estimating the incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01321216 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: March 22, 2011)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
Official Title ^ICMJE	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.
Brief 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.
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 Type ^ICMJE	Observational
Study Design ^ICMJE	Observational Model: Cohort Time Perspective: Prospective
Target Follow-Up Duration	Not Provided
Biospecimen	Retention: Samples With DNA Description: Stool samples with rotavirus RNA
Sampling Method	Non-Probability Sample
Study Population	Children under 5 years of age admitted because of gastroenteritis to 6 major hospitals in Lebanon
Condition ^ICMJE	Gastroenteritis Dehydration
Intervention ^ICMJE	Not Provided
Study Group/Cohort (s)	Hospitalized Gastroenteritis Children under 5 years of age hospitalized with gastroenteritis
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	1600
Estimated Completion Date	June 2013
Estimated Primary Completion Date	January 2013 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	up to 5 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	Lebanon

Administrative Information
NCT Number ^ICMJE	NCT01321216
Other Study ID Numbers ^ICMJE	PED.GD.06
Has Data Monitoring Committee	No
Responsible Party	Dr. Ghassan Dbaibo, American University of Beirut Medical Center
Study Sponsor ^ICMJE	American University of Beirut Medical Center
Collaborators ^ICMJE	Makassed General Hospital Rafic Hariri University Hospital Hotel Dieu de France Hospital Hammoud Hospital Nini Hospital Nabatieh Governmental Hospital
Investigators ^ICMJE	Not Provided
Information Provided By	American University of Beirut Medical Center
Verification Date	January 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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