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