Clinical Evaluation of QFlu Combo Test

Completed

• Conditions: Cough; Fever; Myalgia; Headache; Nasal Obstruction; Sore Throat; Fatigue

• Registration Number: NCT01506583
• Lead Sponsor: Cellex, Inc.

Brief 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.

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 Timeline

• Study Start: 2010-11-01
• Study First Submitted: 2012-01-06
• Study First Submitted QC: 2012-01-09
• Study First Posted: 2012-01-10
• Primary Completion: 2012-05-31
• Study Completion: 2012-05-31
• Status Verified: 2021-08
• Last Update Submitted: 2021-08-05
• Last Update Posted: 2021-08-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 506

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.

Exclusion Criteria

Not provided

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Sensitivity and specificity for drug resistance detection	approximately 12 months after the study is completed.	Interim results may be assessed after the first year study.

Secondary Outcome Measures

Name	Time	Method
Sensitivity and Specificity of the Test for Influenza Diagnosis	12 months after the study is completed.	Results may be assessed after the first year study.

Trial Locations

Locations (3)

Northwestern University Feinberg School of Medicine; 🇺🇸 Chicago, Illinois, United States

University of Maryland School of Medicine; 🇺🇸 Baltimore, Maryland, United States

University of Alabama at Birmingham; 🇺🇸 Birmingham, Alabama, United States