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Clinical Evaluation of QFlu Combo Test

Information source: Cellex, Inc.
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Cough; Myalgia; Nasal Obstruction; Sore Throat; Headache; Fatigue; Fever

Phase: N/A

Status: Recruiting

Sponsored 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.

Clinical Details

Official title: Clinical Evaluation of QFlu Combo Test

Study design: Time Perspective: Prospective

Primary outcome: Sensitivity and specificity for drug resistance detection

Secondary outcome: Sensitivity and Specificity of the Test for Influenza Diagnosis

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.


Minimum age: N/A. Maximum age: N/A. Gender(s): Both.


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.

Locations and Contacts

University of Alabama at Birmingham, Birmingham, Alabama 35294, United States; Recruiting
David Kimberlin, M.D., Phone: 205-934-5316, Email: dkimberlin@peds.uab.edu
Dusty Giles, R.N., Phone: 205-934-7807, Email: dgiles@peds.uab.edu
David Kimberlin, M.D., Principal Investigator

Northwestern University Feinberg School of Medicine, Chicago, Illinois 61611, United States; Recruiting
Mike Ison, M.S., M.D., Phone: 312-695-4186, Email: mgison@northwestern.edu
Mike Ison, M.S., M.D., Principal Investigator

University of Maryland School of Medicine, Baltimore, Maryland 21201, United States; Completed

Additional Information

Starting date: November 2010
Last updated: January 9, 2012

Page last updated: August 23, 2015

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