Clinical Evaluation of QFlu Combo Test

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01506583

Acronym

QFlu

Enrollment

506

Registered

2012-01-10

Start date

2010-11-01

Completion date

2012-05-31

Last updated

2021-08-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cough, Fatigue, Fever, Headache, Myalgia, Nasal Obstruction, Sore Throat

Keywords

cough, myalgia, nasal obstruction, sore throat, headache, fatigue, feverishness, Patients who exhibit flu-like symptoms during a flu season, including cough, myalgia, nasal obstruction, sore throat, headache, fatigue, and/or feverishness.

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.

Interventions

None listed

Study design

Observational model

OTHER

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Healthy volunteers

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.

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results