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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01321216
Recruitment Status : Unknown
Verified January 2013 by Dr. Ghassan Dbaibo, American University of Beirut Medical Center.
Recruitment status was:  Recruiting
First Posted : March 23, 2011
Last Update Posted : February 1, 2013
Sponsor:
Collaborators:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Gastroenteritis Dehydration

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 Design

Study Type : Observational
Estimated Enrollment : 1600 participants
Observational Model: Cohort
Time Perspective: Prospective
Official 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.
Study Start Date : January 2011
Estimated Primary Completion Date : January 2013
Estimated Study Completion Date : June 2013

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Groups and Cohorts

Group/Cohort
Hospitalized Gastroenteritis
Children under 5 years of age hospitalized with gastroenteritis


Outcome Measures

Primary Outcome Measures :
  1. Estimating the incidence of rotavirus gastroenteritis associated hospitalization in children < 5 years of age [ Time Frame: 2 years ]

Secondary Outcome Measures :
  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 ]

Biospecimen Retention:   Samples With DNA
Stool samples with rotavirus RNA

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   up to 5 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Children under 5 years of age admitted because of gastroenteritis to 6 major hospitals in Lebanon
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01321216


Locations
Lebanon
American University of Beirut Recruiting
Beirut, Lebanon
Contact: Ghassan Dbaibo, MD    +9611374374 ext 5752    gdbaibo@aub.edu.lb   
Contact: Carelle Tabet, RN, MSN    +9611374374 ext 5752    ct04@aub.edu.lb   
Principal Investigator: Ghassan Dbaibo, MD         
Makassed General Hospital Recruiting
Beirut, Lebanon
Contact: Mariam Rajab, MD    +9613301846    drmariam1@hotmail.com   
Principal Investigator: Mariam Rajab, MD         
Rafik Hariri University Hospital Recruiting
Beirut, Lebanon
Contact: Hassan Fakhouri, MD    +9613204259    drhassanf@yahoo.com   
Principal Investigator: Hassan Fakhouri, MD         
Nini Hospital Recruiting
Tripoli, Lebanon
Contact: Adlette Inati, MD    +9613228033    adlette.inati@lau.edu.lb   
Principal Investigator: Adlette Inati, MD         
Sponsors and Collaborators
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
More Information

Responsible Party: Dr. Ghassan Dbaibo, Pediatrician Doctor, American University of Beirut Medical Center
ClinicalTrials.gov Identifier: NCT01321216     History of Changes
Other Study ID Numbers: PED.GD.06
First Posted: March 23, 2011    Key Record Dates
Last Update Posted: February 1, 2013
Last Verified: January 2013

Keywords provided by Dr. Ghassan Dbaibo, American University of Beirut Medical Center:
rotavirus
gastroenteritis
children
Pediatric
dehydration
vaccine

Additional relevant MeSH terms:
Gastroenteritis
Dehydration
Gastrointestinal Diseases
Digestive System Diseases
Water-Electrolyte Imbalance
Metabolic Diseases
Pathologic Processes