Clinical trial NCT01321216: Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
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 type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Gastroenteritis
Dehydration
Keywords: rotavirus
gastroenteritis
children
Pediatric
dehydration
vaccine
Lead sponsor: American University of Beirut Medical Center
Sponsor class: OTHER
Collaborators: name: Makassed General Hospital
name: Rafic Hariri University Hospital
name: Hotel Dieu de France Hospital
name: Hammoud Hospital University Medical Center
name: Hopital Nini
name: Nabatieh Governmental Hospital
First posted: 2011-03-23
Enrollment: 1555
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children under 5 years of age admitted because of gastroenteritis to 6 major hospitals in Lebanon

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.

Eligibility 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

Primary outcomes:
measure: Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age
timeFrame: 2 years
Secondary outcomes:
measure: Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program
timeFrame: 2 years
measure: Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age.
timeFrame: 2 years
measure: Determining the Age and Seasonal Distribution of RV Associated Hospitalizations in Children < 5 Years of Age
timeFrame: 2 years
measure: Determining Seasonal Changes and Year-to-year Changes With Respect to Predominant RV Genotypes
timeFrame: 2 years
Other outcomes:
Locations:
city: Beirut
country: Lebanon
facility: American University of Beirut
city: Beirut
country: Lebanon
facility: Makassed General Hospital
city: Beirut
country: Lebanon
facility: Rafik Hariri University Hospital
city: Tripoli
country: Lebanon
facility: Nini Hospital
Study officials:
References: