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Completed

NCT Number: NCT01321216

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

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.

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Key information

Age range

Up to 5 year

Sex eligibility

All sexes

Study type

Observational

Primary location

American University of Beirut, Beirut, Lebanon

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Estimating the Incidence of Rotavirus Gastroenteritis Associated Hospitalization in Children < 5 Years of Age

    Time frame: 2 years

    Incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age was 30.3% by PCR

Secondary outcomes

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

    Time frame: 2 years

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

    Time frame: 2 years

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

    Time frame: 2 years

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

    Time frame: 2 years

Sponsors and collaborators

Lead sponsor

American University of Beirut Medical Center

Other

Collaborators

  • Hammoud Hospital University Medical Center
  • Hopital Nini
  • Hotel Dieu de France Hospital
  • Makassed General Hospital
  • Nabatieh Governmental Hospital
  • Rafic Hariri University Hospital

Registry information

Official study 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.

Important dates

Study start
2011
Primary completion
2014
Study completion
2014
First posted
Mar 23, 2011
Registry last updated
Nov 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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