Ad Sensor-based Real-time Diagnosis of Adenovirus

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by National Taiwan University Hospital
Sponsor:
Information provided by (Responsible Party):
National Taiwan University Hospital
ClinicalTrials.gov Identifier:
NCT02008812
First received: December 6, 2013
Last updated: December 12, 2013
Last verified: December 2013
  Purpose

To develop a real-time diagnostic technique with Ad sensor for Adenovirus detection, the investigators conduct a prospective clinical study. In comparison with results from direct sequencing of Adenovirus, the investigators evaluate the performance of Ad sensor , 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 Adenovirus patients early treatment to reduce the complications and case-fatality rate.


Condition Intervention
Adenovirus
Device: Ad sensor

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Double Blind (Investigator, Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Ad Sensor-based Real-time Diagnosis of Adenovirus

Further study details as provided by National Taiwan University Hospital:

Primary Outcome Measures:
  • The performance of Ad sensor [ Time Frame: 1 Day ] [ Designated as safety issue: No ]
    In comparison with results from viral isolation and RT-PCR of Adenovirus , we evaluate the performance of Ad sensor, including sensitivity, specificity, cross-reaction and reproducibility.


Estimated Enrollment: 200
Study Start Date: August 2011
Estimated Study Completion Date: December 2015
Estimated Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Ad sensor
virus detection
Device: Ad sensor

Ad sensor, 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-Adenovirus and its Adenovirus 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:
  1. Sample acquirement: At National Taiwan University Hospital in Taiwan, we will enroll patients who have Adenovirus infection . We will take three throat swabs for each patient: one for viral isolation, one for RT-PCR and the last for the Ad sensor - based real-time diagnosis.
  2. Ad sensor diagnosis: Ad sensor (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-Adenovirus and its Adenovirus antigen present in patients'and normal samples.
  3. Gold standard: viral isolation and RT-PCR
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

A: The patients with confirmed or suspected infection. B: The healthy person without disease.

Exclusion Criteria:

-

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02008812

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

No publications provided

Responsible Party: National Taiwan University Hospital
ClinicalTrials.gov Identifier: NCT02008812     History of Changes
Other Study ID Numbers: 201108029RD
Study First Received: December 6, 2013
Last Updated: December 12, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by National Taiwan University Hospital:
Adenovirus

Additional relevant MeSH terms:
Adenoviridae Infections
DNA Virus Infections
Virus Diseases

ClinicalTrials.gov processed this record on September 16, 2014