Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus

Enterovirus 71 and Influenza Virus Clinical Trial

Official title:

Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02009735
• Other study ID #: 201203067RIC
• Status: Recruiting
• Phase: N/A
• First received: December 26, 2012
• Last updated: December 12, 2013
• Start date: June 2012
• Est. completion date: October 2015

Study information

• Verified date: December 2013
• Source: National Taiwan University Hospital
• Contact: Shiming Lin, PhD
• Phone: 886-2-23123456
• Email: til[@]ntu.edu.tw
• Is FDA regulated: No
• Health authority: Taiwan: Department of Health
• Study type: Interventional

Clinical Trial Summary

To develop a real-time diagnostic technique with Virosensor for Enterovirus 71 and Influenza Virus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Enterovirus 71 and Influenza Virus, the investigators evaluate the performance of virosensor , including reproducibility, sensitivity, specificity, and cross-reaction. The potential factors which may interfere with the results would be investigated. With such technique, the investigators hope to make early diagnosis and give Enterovirus 71 and Influenza Virus patients early treatment to reduce the complications and case-fatality rate.

Description:

1. Sample acquirement： At National Taiwan University Hospital in Taiwan, we will enroll patients who have influenza-like illness or enterovirus infection . We will take three throat swabs for each patient: one for viral isolation, one for RT-PCR and the last for the Virosensor - based real-time diagnosis.

2. Virosensor diagnosis： Virosensor (structural chip-based optosensing virus probing system), which is for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-influenza-virus (or anti-Enterovirus 71-virus) and its influenza virus antigen (or Enterovirus 71 antigen) present in patients'and normal samples.

3. Gold standard： viral isolation and RT-PCR

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: October 2015
• Est. primary completion date: October 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• The patients with confirmed or suspected infection.

• The healthy person without disease.

Exclusion Criteria:

Study Design

Intervention Model: Single Group Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Enterovirus 71 and Influenza Virus
• Enterovirus Infections
• Influenza, Human

Intervention

Device:
• virosensor
virosensor, which was developed for the rapid and sensitive detection of viral antigen in medical samples, will be used for analyzing the interaction kinetics between anti-influenza-virus (or anti-EV71-virus) and its influenza virus antigen (or EV71 antigen) present in patients and normal samples. The system incorporates the use of chip formats. In antibody probing, antibodies are bound as a suitable probe, which specifically and selectively binds targeted molecules (virus antigen) in the test specimens.

Locations

Country	Name	City	State
Taiwan	National Taiwan University Hospital	Taipei

Sponsors (1)

Lead Sponsor	Collaborator
National Taiwan University Hospital

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Influenza virus or Enterovirus 71 detection	In comparison with results from viral isolation and RT-PCR of influenza virus or Enterovirus 71 , we evaluate the performance of virosensor, including sensitivity, specificity, cross-reaction and reproducibility.	1 Day	No