Clinical Evaluation of QFlu Combo Test (QFlu)

August 5, 2021 updated by: Cellex, Inc.
Currently effective antivials for influenza treatment are two influenza viral neuraminidase inhibitors, oseltamivir (Tamiflu) and zanamivir (Relenza). Resistance to these drugs is reflected by reduced susceptibility of viral neuraminidase to these drugs. The hypothesis is that the signal ratio of two reagents (with or without a single concentration of the drug) correlates the IC50 value, an accurate measurement of drug resistance but impractical for clinical use.

Study Overview

Status

Completed

Conditions

Detailed Description

The study design is to collect samples from participants. A portion of the sample is used for drug resistance detection using the test (QFlu Combo Test) under investigation. The remaining portion of the sample is used for culture. The culture positive samples are used for determination of IC50 values, which is used as a gold standard for defining whether a virus isolate is resistant to a drug or not. The sensitivity and specificity of the QFlu test will be calculated by comparing to the gold standard test.

Study Type

Observational

Enrollment (Actual)

506

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • University of Alabama at Birmingham
    • Illinois
      • Chicago, Illinois, United States, 61611
        • Northwestern University Feinberg School of Medicine
    • Maryland
      • Baltimore, Maryland, United States, 21201
        • University of Maryland School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

There are three population of participants: pediatric (in patient or out patient), in-patient (any age) and out-patient (any age).

Description

Inclusion Criteria:

  • Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
General population
This group of participants is primarily an out-patient population.
In-patient population
This group of participants is primarily an in-patient population.
Pediatric Group
Participants in this group are children 18 years or younger.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity for drug resistance detection
Time Frame: approximately 12 months after the study is completed.
Interim results may be assessed after the first year study.
approximately 12 months after the study is completed.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and Specificity of the Test for Influenza Diagnosis
Time Frame: 12 months after the study is completed.
Results may be assessed after the first year study.
12 months after the study is completed.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cellex, Inc.

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

November 1, 2010

Primary Completion (Actual)

May 31, 2012

Study Completion (Actual)

May 31, 2012

Study Registration Dates

First Submitted

January 6, 2012

First Submitted That Met QC Criteria

January 9, 2012

First Posted (Estimate)

January 10, 2012

Study Record Updates

Last Update Posted (Actual)

August 6, 2021

Last Update Submitted That Met QC Criteria

August 5, 2021

Last Verified

August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cellex002
  • 2R44AI082728-02 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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