NCT Number: NCT03550937
Hospital-based Surveillance of Rotavirus Gastroenteritis 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.
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Notify MeKey information
Age range
Up to 5 year
Sex eligibility
All sexes
Study type
Observational
Primary location
Chang Bing Show Chwan Memorial Hospital, Chang-hua, Taiwan
Who can participate
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Primary outcomes
-
monitor the strain diversity of rotavirus in Taiwan
Time frame: 4 years
monitor the strain diversity of rotavirus in Taiwan, including the individual serotype prevalence and emerging genotypes
Sponsors and collaborators
Lead sponsor
National Taiwan University Hospital
Other
Registry information
Official study title
Hospital-based Surveillance of Severe Rotavirus Gastroenteritis and Diversity of Circulating Rotavirus Strains in Young Taiwanese Children
Important dates
- Study start
- 2013
- Primary completion
- 2018
- Study completion
- 2018
- First posted
- Jun 8, 2018
- Registry last updated
- Jun 18, 2018
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.