Clinical Evaluation of QFlu Combo Test

Fatigue Clinical Trial

— QFlu  

Official title:

Clinical Evaluation of QFlu Combo Test

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01506583
• Other study ID #: Cellex002
• Secondary ID: 2R44AI082728-02
• Status: Completed
• Start date: November 1, 2010
• Est. completion date: May 31, 2012

Study information

• Verified date: August 2021
• Source: Cellex, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 506
• Est. completion date: May 31, 2012
• Est. primary completion date: May 31, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Cough
• Fatigue
• Fever
• Headache
• Myalgia
• Nasal Obstruction
• Pharyngitis
• Sore Throat

Locations

Country	Name	City	State
United States	University of Maryland School of Medicine	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Northwestern University Feinberg School of Medicine	Chicago	Illinois

Sponsors (2)

Lead Sponsor	Collaborator
Cellex, Inc.	National Institute of Allergy and Infectious Diseases (NIAID)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Sensitivity and specificity for drug resistance detection	Interim results may be assessed after the first year study.	approximately 12 months after the study is completed.
Secondary	Sensitivity and Specificity of the Test for Influenza Diagnosis	Results may be assessed after the first year study.	12 months after the study is completed.