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Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus
The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2013 by National Taiwan University Hospital.
Recruitment status was: Recruiting
Recruitment status was: Recruiting
Sponsor:
National Taiwan University Hospital
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02009735
First received: December 26, 2012
Last updated: December 12, 2013
Last verified: December 2013
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Purpose
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.
| Condition | Intervention |
|---|---|
| Enterovirus 71 and Influenza Virus | Device: virosensor |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Double Blind (Investigator, Outcomes Assessor) Primary Purpose: Diagnostic |
| Official Title: | Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus |
Resource links provided by NLM:
Further study details as provided by National Taiwan University Hospital:
Primary Outcome Measures:
- Influenza virus or Enterovirus 71 detection [ Time Frame: 1 Day ]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.
| Estimated Enrollment: | 600 |
| Study Start Date: | June 2012 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2015 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: virosensor
virus detection
|
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. |
Detailed Description:
- 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.
- 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.
- Gold standard： viral isolation and RT-PCR
Eligibility| Ages Eligible for Study: | Child, Adult, Senior |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- The patients with confirmed or suspected infection.
- The healthy person without disease.
Exclusion Criteria:
Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT02009735
Please refer to this study by its ClinicalTrials.gov identifier: NCT02009735
Contacts
| Contact: Shiming Lin, PhD | 886-2-23123456 ext 88458 | til@ntu.edu.tw |
Locations
| Taiwan | |
| National Taiwan University Hospital | Recruiting |
| Taipei, Taiwan, 10051 | |
| Contact: Luan-Yin Chang , MD,PhD 886-2-2312-3456 ext 71528 lychang@ntu.edu.tw | |
Sponsors and Collaborators
National Taiwan University Hospital
More Information
| Responsible Party: | National Taiwan University Hospital |
| ClinicalTrials.gov Identifier: | NCT02009735 History of Changes |
| Other Study ID Numbers: |
201203067RIC |
| Study First Received: | December 26, 2012 |
| Last Updated: | December 12, 2013 |
Keywords provided by National Taiwan University Hospital:
|
Enterovirus 71 and Influenza Virus |
Additional relevant MeSH terms:
|
Influenza, Human Enterovirus Infections Orthomyxoviridae Infections RNA Virus Infections |
Virus Diseases Respiratory Tract Infections Respiratory Tract Diseases Picornaviridae Infections |
ClinicalTrials.gov processed this record on July 24, 2017