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

This study is currently recruiting participants.
Verified January 2013 by American University of Beirut Medical Center
Sponsor:
Collaborators:
Makassed General Hospital
Rafic Hariri University Hospital
Hotel Dieu de France Hospital
Hammoud Hospital
Nini Hospital
Nabatieh Governmental Hospital
Information provided by (Responsible Party):
Dr. Ghassan Dbaibo, American University of Beirut Medical Center
ClinicalTrials.gov Identifier:
NCT01321216
First received: March 22, 2011
Last updated: January 31, 2013
Last verified: January 2013

March 22, 2011
January 31, 2013
January 2011
January 2013   (final data collection date for primary outcome measure)
Estimating the incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01321216 on ClinicalTrials.gov Archive Site
  • Identifying the most prevalent RV genotypes in the target population included in the surveillance program [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Estimating the proportion of diarrheal hospitalization due to RV in children < 5 years of age. [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Determining the age and seasonal distribution of RV associated hospitalizations in children < 5 years of age [ Time Frame: 2 years ] [ Designated as safety issue: No ]
  • Determining seasonal changes and year-to-year changes with respect to predominant RV genotypes [ Time Frame: 2 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Rotavirus Burden and Genotypes in a Sentinel Hospital Surveillance System in Lebanon
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.

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.

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.

Observational
Observational Model: Cohort
Time Perspective: Prospective
Not Provided
Retention:   Samples With DNA
Description:

Stool samples with rotavirus RNA

Non-Probability Sample

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

  • Gastroenteritis
  • Dehydration
Not Provided
Hospitalized Gastroenteritis
Children under 5 years of age hospitalized with gastroenteritis
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
1600
June 2013
January 2013   (final data collection date for primary outcome measure)

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
Both
up to 5 Years
No
Not Provided
Lebanon
 
NCT01321216
PED.GD.06
No
Dr. Ghassan Dbaibo, American University of Beirut Medical Center
American University of Beirut Medical Center
  • Makassed General Hospital
  • Rafic Hariri University Hospital
  • Hotel Dieu de France Hospital
  • Hammoud Hospital
  • Nini Hospital
  • Nabatieh Governmental Hospital
Not Provided
American University of Beirut Medical Center
January 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP