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

NCT ID: NCT01321216

Last Updated: 2023-11-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 1555 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2011-12-31
• Study Completion Date: 2014-06-30

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.

Conditions

Gastroenteritis; Dehydration

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Hospitalized Gastroenteritis

Children under 5 years of age hospitalized with gastroenteritis

No interventions assigned to this group

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

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Makassed General Hospital

OTHER

Sponsor Role: collaborator

Rafic Hariri University Hospital

OTHER

Sponsor Role: collaborator

Hotel Dieu de France Hospital

OTHER

Sponsor Role: collaborator

Hammoud Hospital University Medical Center

OTHER_GOV

Sponsor Role: collaborator

Hopital Nini

OTHER

Sponsor Role: collaborator

Nabatieh Governmental Hospital

OTHER

Sponsor Role: collaborator

American University of Beirut Medical Center

OTHER

Sponsor Role: lead

Responsible Party

Dr. Ghassan Dbaibo

Pediatrician Doctor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

American University of Beirut

Beirut, , Lebanon

Makassed General Hospital

Beirut, , Lebanon

Rafik Hariri University Hospital

Beirut, , Lebanon

Nini Hospital

Tripoli, , Lebanon

Countries

Lebanon

Other Identifiers

PED.GD.06

Identifier Type: -

Identifier Source: org_study_id