Clinical trial NCT03550937: Hospital-based Surveillance of Rotavirus Gastroenteritis in Young Taiwanese Children
Official title: Hospital-based Surveillance of Severe Rotavirus Gastroenteritis and Diversity of Circulating Rotavirus Strains in Young Taiwanese Children
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Rotavirus Gastroenteritis, Young Taiwanese Children
Lead sponsor: National Taiwan University Hospital
Sponsor class: OTHER
First posted: 2018-06-08
Enrollment: 5040
Sex: ALL
Maximum age (years): 5
Standard ages: CHILD
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Hospitalized children having diarrhea and less than 60 months of age

Brief summary: Rotavirus remains among the leading causes of pediatric gastroenteritis requiring hospitalization in the world. Surveillance studies revealed that more than 90% of the global circulating rotavirus strains were predominated by several major genotypes. Clinical trials and post-marketing studies have demonstrated that the currently available rotavirus vaccine can provide sufficient protection against strains of the prevalent genotypes. However, the emerging strains with new genotypes were increasingly reported in the past decade, an ongoing surveillance of the strain changes is needed in the regions where the pediatric population is either fully or partly immunized. In this project, the investigators will setup a hospital-based gastroenteritis surveillance network by incorporating 8 major hospitals in northern, central, southern and eastern Taiwan. From 2013 to 2015, children aged 5 years or younger hospitalized to one of the 8 sentinel hospitals due to acute gastroenteritis will be screened for rotavirus infection, and viral proteins 7 \[VP7\] (G type) and viral proteins 4 \[VP4\] (P type) genotypes of rotavirus will be determined for each infected case. The demographics and clinical manifestations of study subjects will also be collected and analyzed. Through this project, the investigators will be able to detect emerging genotypes of rotavirus and delineate the strain distribution during the two years of study in Taiwan. The investigators can also have more comprehensive understanding of the epidemiology of rotavirus regarding to the incidence, disease characteristics, temporal and geographic variations of severe rotavirus gastroenteritis in Taiwanese children. Results from this project will provide valuable information for future implementation of mass immunization against rotavirus in Taiwan.


Eligibility criteria: Inclusion Criteria:

* aged less than 60 months,
* hospitalized in 1 of the 8 hospitals,
* having diarrhea not caused by any known underlying diseases.

Exclusion Criteria:

* No

Primary outcomes:
measure: monitor the strain diversity of rotavirus in Taiwan
timeFrame: 4 years
Secondary outcomes:
Other outcomes:
Locations:
city: Chang Hua
country: Taiwan
facility: Chang Bing Show Chwan Memorial Hospital
city: Chang Hua
country: Taiwan
facility: Chang Hua Show Chwan Memorial Hospital
city: Douliu
country: Taiwan
facility: National Taiwan University Hospital Yun-Lin Branch
city: Hualien City
country: Taiwan
facility: Buddhist Tzu Chi General Hospital, Hualien Tzu Chi Medical Center
city: Kaohsiung
country: Taiwan
facility: Kaohsiung Chang Gung Memorial Hospital
city: Taichung
country: Taiwan
facility: China Medical University Hospital
city: Tainan
country: Taiwan
facility: National Cheng Kung University Hospital
city: Taipei
country: Taiwan
facility: Mackay Memorial Hospital
city: Taipei
country: Taiwan
facility: National Taiwan University Hospital
city: Taoyuan
country: Taiwan
facility: Chang Gung Children's Hospital
Study officials:
References: