Clinical Evaluation of QFlu Combo Test
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 Design:||Time Perspective: Prospective|
|Official Title:||Clinical Evaluation of QFlu Combo Test|
- Sensitivity and specificity for drug resistance detection [ Time Frame: approximately 12 months after the study is completed. ] [ Designated as safety issue: No ]Interim results may be assessed after the first year study.
- Sensitivity and Specificity of the Test for Influenza Diagnosis [ Time Frame: 12 months after the study is completed. ] [ Designated as safety issue: No ]Results may be assessed after the first year study.
Biospecimen Retention: Samples Without DNA
Samples were retained in case that the testing needs to be repeated. They are to be discarded 12 months after the study is completed.
|Study Start Date:||November 2010|
|Estimated Study Completion Date:||July 2012|
|Estimated Primary Completion Date:||May 2012 (Final data collection date for primary outcome measure)|
This group of participants is primarily an out-patient population.
This group of participants is primarily an in-patient population.
Participants in this group are children 18 years or younger.
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.
|United States, Alabama|
|University of Alabama at Birmingham||Recruiting|
|Birmingham, Alabama, United States, 35294|
|Contact: David Kimberlin, M.D. 205-934-5316 firstname.lastname@example.org|
|Contact: Dusty Giles, R.N. 205-934-7807 email@example.com|
|Principal Investigator: David Kimberlin, M.D.|
|United States, Illinois|
|Northwestern University Feinberg School of Medicine||Recruiting|
|Chicago, Illinois, United States, 61611|
|Contact: Mike Ison, M.S., M.D. 312-695-4186 firstname.lastname@example.org|
|Principal Investigator: Mike Ison, M.S., M.D.|
|United States, Maryland|
|University of Maryland School of Medicine||Completed|
|Baltimore, Maryland, United States, 21201|