Hospital-based Surveillance of Rotavirus Gastroenteritis in Young Taiwanese Children

NCT ID: NCT03550937

Last Updated: 2018-06-18

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 5040 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2013-12-11
• Study Completion Date: 2018-02-06

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.

Conditions

Rotavirus Gastroenteritis, Young Taiwanese Children

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

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

• Maximum Eligible Age: 5 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Taiwan University Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Chang Bing Show Chwan Memorial Hospital

Chang-hua, , Taiwan

Chang Hua Show Chwan Memorial Hospital

Chang-hua, , Taiwan

National Taiwan University Hospital Yun-Lin Branch

Douliu, , Taiwan

Buddhist Tzu Chi General Hospital, Hualien Tzu Chi Medical Center

Hualien City, , Taiwan

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, , Taiwan

China Medical University Hospital

Taichung, , Taiwan

National Cheng Kung University Hospital

Tainan City, , Taiwan

Mackay Memorial Hospital

Taipei, , Taiwan

National Taiwan University Hospital

Taipei, , Taiwan

Chang Gung Children's Hospital

Taoyuan District, , Taiwan

Countries

Taiwan

Other Identifiers

201310064RINA

Identifier Type: -

Identifier Source: org_study_id