Hospital-based Surveillance of Rotavirus Gastroenteritis in Young Taiwanese Children

Hospital-based Surveillance of Severe Rotavirus Gastroenteritis and Diversity of Circulating Rotavirus Strains in Young Taiwanese Children

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.

Study Overview

• Status: Completed
• Conditions: Rotavirus Gastroenteritis, Young Taiwanese Children

• Study Type: Observational
• Enrollment (Actual): 5040

Contacts and Locations

Study Locations

• Taiwan
  • Chang Hua, Taiwan
    • Chang Bing Show Chwan Memorial Hospital
  • Chang Hua, Taiwan
    • Chang Hua Show Chwan Memorial Hospital
  • Douliu, Taiwan
    • National Taiwan University Hospital Yun-Lin Branch
  • Hualien City, Taiwan
    • Buddhist Tzu Chi General Hospital, Hualien Tzu Chi Medical Center
  • Kaohsiung, Taiwan
    • Kaohsiung Chang Gung Memorial Hospital
  • Taichung, Taiwan
    • China Medical University Hospital
  • Tainan, Taiwan
    • National Cheng Kung University Hospital
  • Taipei, Taiwan
    • Mackay Memorial Hospital
  • Taipei, Taiwan
    • National Taiwan University Hospital
  • Taoyuan, Taiwan
    • Chang Gung Children's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 5 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospitalized children having diarrhea and less than 60 months of age

Description

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

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
monitor the strain diversity of rotavirus in Taiwan	monitor the strain diversity of rotavirus in Taiwan, including the individual serotype prevalence and emerging genotypes	4 years

Collaborators and Investigators

• Sponsor: National Taiwan University Hospital

Study record dates

Study Major Dates

• Study Start (Actual): December 11, 2013
• Primary Completion (Actual): February 6, 2018
• Study Completion (Actual): February 6, 2018

Study Registration Dates

• First Submitted: May 28, 2018
• First Submitted That Met QC Criteria: May 28, 2018
• First Posted (Actual): June 8, 2018

Study Record Updates

• Last Update Posted (Actual): June 18, 2018
• Last Update Submitted That Met QC Criteria: June 15, 2018
• Last Verified: May 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Digestive System Diseases; Gastrointestinal Diseases; Gastroenteritis
• Other Study ID Numbers: 201310064RINA

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No