Clinical trial NCT01253967: Surveillance Study to Estimate the Proportion of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
Official title: Hospital-based Surveillance to Estimate the Disease Burden of Rotavirus Gastroenteritis in Children < 5 Years of Age in Romania
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infections, Rotavirus
Keywords: Gastroenteritis
Hospital surveillance
Rotavirus gastroenteritis
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2010-12-06
Enrollment: 1234
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 treated at a hospital site (subjects hospitalised with community acquired acute gastroenteritis, subjects who visited the emergency room for acute gastroenteritis or subjects with medical care associated rotavirus infection).

Brief summary: The purpose of this hospital based study is to estimate the proportion of rotavirus gastroenteritis in children \< 5 years of age in Romania.

Detailed description: The study consist of a main study and a health economics study

Main study: The study will focus on three different groups of patients:

* Subjects who are hospitalised for acute gastroenteritis.
* Subjects who visit an emergency room for acute gastroenteritis.
* Subjects who have rotavirus positive laboratory results and developed acute gastroenteritis at least 48 hours after hospitalisation.

Health economics study: for a subset of subjects, additional economic data will be gathered by completing a questionnaire

Eligibility criteria: Inclusion Criteria:

* A male or female child aged \< 5 years at the time of admission. A child becomes ineligible on the day of her/his fifth birthday.
* A subject, who during the study period:

  * Is hospitalised for acute gastroenteritis Or
  * Visits an emergency room for acute gastroenteritis Or
  * Has rotavirus positive laboratory results and develops acute gastroenteritis at least 48 hours after hospitalisation

Exclusion Criteria:

Not applicable

Primary outcomes:
measure: Proportion of rotavirus gastroenteritis among all acute gastroenteritis hospitalisations of children < 5 years of age
timeFrame: At least 12 months from study start
measure: Proportion of rotavirus gastroenteritis among all acute gastroenteritis emergency room visits for children < 5 years of age
timeFrame: At least 12 months from study start
measure: Incidence of medical care associated rotavirus gastroenteritis among all hospitalised children < 5 years of age
timeFrame: At least 12 months from study start
Secondary outcomes:
measure: Age distribution of children with rotavirus gastroenteritis
timeFrame: At least 12 months from study start
measure: Percentage of rotavirus genotypes amongst all isolated strains in children < 5 years of age
timeFrame: At least 12 months from study start
measure: Potential risk factors for rotavirus gastroenteritis
timeFrame: At least 12 months from study start
measure: Rotavirus gastroenteritis associated costs
timeFrame: At least 12 months from study start
measure: Proportion of acute gastroenteritis among all hospitalisations of children < 5 years of age
timeFrame: At least 12 months from study start
measure: Proportion of community acquired acute gastroenteritis among all emergency room visits for children < 5 years of age
timeFrame: At least 12 months from study start
measure: Seasonal distribution (if appropriate) of rotavirus among all children < 5 years of age
timeFrame: At least 12 months from study start
measure: Severity of rotavirus among all children < 5 years of age
timeFrame: At least 12 months from study
measure: Proportion of rotavirus gastroenteritis among all hospitalisations of children < 5 years of age
timeFrame: At least 12 months from study start
measure: Proportion of community acquired rotavirus gastroenteritis among all emergency room visits for children < 5 years of age
timeFrame: At least 12 months from study start
Other outcomes:
Locations:
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Bucharest
country: Romania
facility: GSK Investigational Site
city: Cluj Napoca
country: Romania
facility: GSK Investigational Site
city: Cluj
country: Romania
facility: GSK Investigational Site
city: Constanta
country: Romania
facility: GSK Investigational Site
city: Craiova
country: Romania
facility: GSK Investigational Site
city: Sibiu
country: Romania
facility: GSK Investigational Site
city: Timisoara
country: Romania
facility: GSK Investigational Site
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Benea OE, Streinu-Cercel A, Dorobat C, Rugina S, Negrutiu L, Cupsa A, Duiculescu D, Chiriac C, Itu C, Prisacariu LJ, Iosif I. Efficacy and safety of darunavir (Prezista((R))) with low-dose ritonavir and other antiretroviral medications in subtype F HIV-1 infected, treatment-experienced subjects in Romania: a post-authorization, open-label, one-cohort, non-interventional, prospective study. Germs. 2014 Sep 1;4(3):59-69. doi: 10.11599/germs.2014.1057. eCollection 2014 Sep.
citation: Anca IA, Furtunescu FL, Plesca D, Streinu-Cercel A, Rugina S, Holl K. Hospital-based surveillance to estimate the burden of rotavirus gastroenteritis in children below five years of age in Romania. Germs. 2014 Jun 2;4(2):30-40. doi: 10.11599/germs.2014.1053. eCollection 2014 Jun.