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

NCT01321216 | Completed Results

• 1 other identifier: PED.GD.06
• Study Type: observational
• Target: 1,555
• Locations: 1 country
• Sites: 4

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.

Conditions

Gastroenteritis; Dehydration

Keywords

rotavirus; gastroenteritis; children; Pediatric; dehydration; vaccine

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (4)

• Identifying the Most Prevalent RV Genotypes in the Target Population Included in the Surveillance Program

  2 years

• Estimating the Proportion of Diarrheal Hospitalization Due to RV in Children < 5 Years of Age.

  2 years

• Determining the Age and Seasonal Distribution of RV Associated Hospitalizations in Children < 5 Years of Age

  2 years

• Determining Seasonal Changes and Year-to-year Changes With Respect to Predominant RV Genotypes

  2 years

Study Arms (1)

Hospitalized Gastroenteritis

Children under 5 years of age hospitalized with gastroenteritis

Eligibility Criteria

• Age: Up to 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)
• Sampling Method: Non-Probability Sample

Study Population

Children under 5 years of age admitted because of gastroenteritis to 6 major hospitals in Lebanon

You may qualify if:

• Age \< 5 years
• Gastroenteritis as admitting diagnosis
• Informed consent
• Parents willing and able to cooperate

You may not qualify if:

• Age \> 5 years
• Onset of gastroenteritis beyond 12 hours of admission

Sponsors & Collaborators

• American University of Beirut Medical Center: lead
• Makassed General Hospital: collaborator
• Rafic Hariri University Hospital: collaborator
• Hotel Dieu de France Hospital: collaborator
• Hammoud Hospital University Medical Center: collaborator
• Hopital Nini: collaborator
• Nabatieh Governmental Hospital: collaborator

Study Sites (4)

American University of Beirut

Beirut, Lebanon

Location

Makassed General Hospital

Beirut, Lebanon

Location

Rafik Hariri University Hospital

Beirut, Lebanon

Location

Nini Hospital

Tripoli, Lebanon

Location

Biospecimen

Retention: SAMPLES WITH DNA

Stool samples with rotavirus RNA

MeSH Terms

Conditions

Gastroenteritis; Dehydration

Condition Hierarchy (Ancestors)

Gastrointestinal Diseases; Digestive System Diseases; Water-Electrolyte Imbalance; Metabolic Diseases; Nutritional and Metabolic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Dr Ghassan Dbaibo
• Organization: American University of Beirut

gdbaibo@aub.edu.lb

961-1-350000

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatrician Doctor

Study Record Dates

• First Submitted: March 22, 2011
• First Posted: March 23, 2011
• Study Start: December 1, 2011
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: November 18, 2023
• Results First Posted: November 18, 2023

Record last verified: 2023-02

Locations

LE (4)