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

Completed

• Conditions: Dehydration; Gastroenteritis

• Registration Number: NCT01321216
• Lead Sponsor: American University of Beirut Medical Center

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 Timeline

• Study First Submitted: 2011-03-22
• Study First Submitted QC: 2011-03-22
• Study First Posted: 2011-03-23
• Study Start: 2011-12
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2023-02
• Results First Submitted: 2023-02-02
• Results First Submitted QC: 2023-02-02
• Last Update Submitted: 2023-02-02
• Results First Posted: 2023-11-18
• Last Update Posted: 2023-11-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1555

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age	2 years	Incidence of rotavirus gastroenteritis associated hospitalization in children \< 5 years of age was 30.3% by PCR

Secondary Outcome Measures

Name	Time	Method
Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age.	2 years
Determining Seasonal Changes and Year-to-year Changes With Respect to Predominant RV Genotypes	2 years
Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program	2 years
Determining the Age and Seasonal Distribution of RV Associated Hospitalizations in Children < 5 Years of Age	2 years

Trial Locations

Locations (4)

Rafik Hariri University Hospital; 🇱🇧 Beirut, Lebanon

American University of Beirut; 🇱🇧 Beirut, Lebanon

Makassed General Hospital; 🇱🇧 Beirut, Lebanon

Nini Hospital; 🇱🇧 Tripoli, Lebanon