Back to resultsClinical Performance of the Diassess Influenza A and B Test
Primary Purpose
Influenza, Human, Influenza, Flu
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Diassess Influenza A and B Test
Sponsored by
About this trial
This is an interventional device feasibility trial for Influenza, Human
Eligibility Criteria
Inclusion Criteria:
- Subject currently has a fever (≥37.8°C/100°F), or self-reports having had or is currently treating a fever ≥37.8°C/100°F with onset within the previous 72 hrs
- Subject has at least one additional flu-like symptom including fever or feeling feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired), sore throat, headaches, or cough
Exclusion Criteria:
- Subject received nasal vaccine (e.g. FluMist) within the past 10 days
- Subject has been taking or took any antivirals for influenza in the past 30 days
- Subject enrolled in any drug trials
Sites / Locations
- University Health Care Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Diassess Influenza A and B Test
Arm Description
Outcomes
Primary Outcome Measures
Diassess test measurement agreement with Polymerase Chain Reaction (PCR)
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03035396
Brief Title
Clinical Performance of the Diassess Influenza A and B Test
Official Title
Clinical Performance of the Diassess Influenza A and B Test
Study Type
Interventional
2. Study Status
Record Verification Date
February 2018
Overall Recruitment Status
Completed
Study Start Date
December 29, 2016 (Actual)
Primary Completion Date
May 2017 (Actual)
Study Completion Date
May 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Diassess Inc.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The primary objective of this study is device feasibility of the Diassess Influenza A and B Test
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Influenza, Human, Influenza, Flu
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
567 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Diassess Influenza A and B Test
Arm Type
Experimental
Intervention Type
Device
Intervention Name(s)
Diassess Influenza A and B Test
Primary Outcome Measure Information:
Title
Diassess test measurement agreement with Polymerase Chain Reaction (PCR)
Time Frame
One (1) patient visit which is a time frame of one (1) hour
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subject currently has a fever (≥37.8°C/100°F), or self-reports having had or is currently treating a fever ≥37.8°C/100°F with onset within the previous 72 hrs
Subject has at least one additional flu-like symptom including fever or feeling feverish/chills, runny or stuffy nose, muscle or body aches, fatigue (very tired), sore throat, headaches, or cough
Exclusion Criteria:
Subject received nasal vaccine (e.g. FluMist) within the past 10 days
Subject has been taking or took any antivirals for influenza in the past 30 days
Subject enrolled in any drug trials
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Carol Chen, PhD
Organizational Affiliation
Diassess Inc.
Official's Role
Study Director
Facility Information:
Facility Name
University Health Care Center
City
Syracuse
State/Province
New York
ZIP/Postal Code
13202
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Clinical Performance of the Diassess Influenza A and B Test
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