Clinical trial NCT00751686: Estimation of the Burden of Rotavirus Gastroenteritis (RV GE) in Children Less Than 5 Years in Greece
Official title: To Estimate the Burden of Rotavirus Gastroenteritis (RV GE) in Children < 5 Years of Age in Greece
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotavirus Gastroenteritis
Keywords: Gastroenteritis
Burden
Rotavirus
< 5 years
Greece
Children
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2008-09-12
Enrollment: 128
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Children \< 5 years of age seen at the selected hospital sites for acute GE (e.g. subjects treated at the hospital or visiting the emergency room for an acute GE episode or developed acute GE at least 48 hours after hospitalisation) with a rapid screen positive test result to RV.

Brief summary: The purpose of this study is to measure the disease burden from RV GE among children less than 5 years of age using hospital surveillance data. In addition, data collected will determine the seasonal distribution, disease severity, age distribution of RV GE. From an economic standpoint, the cost and impact of RV will also be assessed.


Eligibility criteria: Inclusion Criteria:

* A male or female child \< 5 years of age at the time of the visit (a child becomes ineligible on the day of her/his 5th birthday).
* Child is brought to the emergency room for acute GE during the study period or develop acute GE at least 48 hours after hospitalisation.
* Written informed consent obtained from the parent/guardian of the subject.
* Children with RV positive stool sample will be enrolled in the study.

Exclusion Criteria:

• Not applicable.

Primary outcomes:
measure: Estimation of the proportion of RV GE among all acute GE emergency room visits among children <5 years of age.
timeFrame: Approximately 12 months
measure: Estimation of the proportion of RV GE among all acute GE hospitalisations among children <5 years of age.
timeFrame: Approximately 12 months
measure: Estimation of the incidence of nosocomial RV GE among all hospitalised children <5 years of age.
timeFrame: Approximately 12 months
Secondary outcomes:
measure: Determination of the age of the children, disease severity, and the seasonal distribution of RV GE among children <5 years of age.
timeFrame: Approximately 12 months
measure: Assessing the costs related to the episodes of RV GE, by the completion of the Health Economic Questionnaire (interview with the parent for a subset of subjects) and the cost checklist provided by the hospital's site staff.
timeFrame: Approximately 12 months
measure: Identification of prevalent genotypes of RV among children <5 years of age.
timeFrame: Approximately 12 months
Other outcomes:
Locations:
city: Athens
country: Greece
facility: GSK Investigational Site
city: Athens
country: Greece
facility: GSK Investigational Site
city: Heraklion, Crete
country: Greece
facility: GSK Investigational Site
city: Rio/Patras
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
city: Thessaloniki
country: Greece
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Konstantopoulos A, Tragiannidis A, Fouzas S, Kavaliotis I, Tsiatsou O, Michailidou E, Spanaki A, Mantagos S, Kafetzis D, Papaevangelou V, Gopala K, Holl K. Burden of rotavirus gastroenteritis in children <5 years of age in Greece: hospital-based prospective surveillance (2008-2010). BMJ Open. 2013 Dec 11;3(12):e003570. doi: 10.1136/bmjopen-2013-003570.