Hospital-based Surveillance of Rotavirus Gastroenteritis in Young Taiwanese Children

Completed

• Conditions: Rotavirus Gastroenteritis, Young Taiwanese Children

• Registration Number: NCT03550937
• Lead Sponsor: National Taiwan University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-11
• Primary Completion: 2018-02-06
• Study Completion: 2018-02-06
• Status Verified: 2018-05
• Study First Submitted: 2018-05-28
• Study First Submitted QC: 2018-05-28
• Study First Posted: 2018-06-08
• Last Update Submitted: 2018-06-15
• Last Update Posted: 2018-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 5040

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
monitor the strain diversity of rotavirus in Taiwan	4 years	monitor the strain diversity of rotavirus in Taiwan, including the individual serotype prevalence and emerging genotypes

Trial Locations

Locations (10)

Chang Hua Show Chwan Memorial Hospital; 🇨🇳 Chang Hua, Taiwan

Kaohsiung Chang Gung Memorial Hospital; 🇨🇳 Kaohsiung, Taiwan

Chang Bing Show Chwan Memorial Hospital; 🇨🇳 Chang Hua, Taiwan

Buddhist Tzu Chi General Hospital, Hualien Tzu Chi Medical Center; 🇨🇳 Hualien City, Taiwan

National Taiwan University Hospital Yun-Lin Branch; 🇨🇳 Douliu, Taiwan

China Medical University Hospital; 🇨🇳 Taichung, Taiwan

Chang Gung Children's Hospital; 🇨🇳 Taoyuan, Taiwan

Mackay Memorial Hospital; 🇨🇳 Taipei, Taiwan

National Taiwan University Hospital; 🇨🇳 Taipei, Taiwan

National Cheng Kung University Hospital; 🇨🇳 Tainan, Taiwan