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

Dehydration Clinical Trial

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01321216
• Other study ID #: PED.GD.06
• Status: Completed
• Start date: December 2011
• Est. completion date: June 2014

Study information

• Verified date: February 2023
• Source: American University of Beirut Medical Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1555
• Est. completion date: June 2014
• Est. primary completion date: June 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A to 5 Years

Eligibility

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

Related Conditions & MeSH terms

• Dehydration
• Gastroenteritis

Locations

Country	Name	City	State
Lebanon	American University of Beirut	Beirut
Lebanon	Makassed General Hospital	Beirut
Lebanon	Rafik Hariri University Hospital	Beirut
Lebanon	Nini Hospital	Tripoli

Sponsors (7)

Lead Sponsor	Collaborator
American University of Beirut Medical Center	Hammoud Hospital University Medical Center, Hopital Nini, Hotel Dieu de France Hospital, Makassed General Hospital, Nabatieh Governmental Hospital, Rafic Hariri University Hospital

Country where clinical trial is conducted

Lebanon, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age	Incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age was 30.3% by PCR	2 years
Secondary	Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program		2 years
Secondary	Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age.		2 years
Secondary	Determining the Age and Seasonal Distribution of RV Associated Hospitalizations in Children < 5 Years of Age		2 years
Secondary	Determining Seasonal Changes and Year-to-year Changes With Respect to Predominant RV Genotypes		2 years