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

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ClinicalTrials.gov Identifier: NCT02009735
Recruitment Status : Unknown
Verified December 2013 by National Taiwan University Hospital.
Recruitment status was:  Recruiting
First Posted : December 12, 2013
Last Update Posted : December 16, 2013
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital

Tracking Information
First Submitted Date  ICMJE December 26, 2012
First Posted Date  ICMJE December 12, 2013
Last Update Posted Date December 16, 2013
Study Start Date  ICMJE June 2012
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: December 12, 2013)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: December 11, 2013)
The performance of virosensor [ 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.
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus
Official Title  ICMJE Virosensor -Based Real-time Diagnosis of Enterovirus 71 and Influenza Virus
Brief 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.
Detailed 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
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Condition  ICMJE Enterovirus 71 and Influenza Virus
Intervention  ICMJE 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.

Study Arms  ICMJE Experimental: virosensor
virus detection
Intervention: Device: virosensor
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: December 11, 2013)
600
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE October 2015
Estimated Primary Completion Date October 2015   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • The patients with confirmed or suspected infection.
  • The healthy person without disease.

Exclusion Criteria:

  • None
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE Child, Adult, Older Adult
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02009735
Other Study ID Numbers  ICMJE 201203067RIC
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party National Taiwan University Hospital
Study Sponsor  ICMJE National Taiwan University Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account National Taiwan University Hospital
Verification Date December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP