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.

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Key information

Conditions

Cough Airway Obstruction Body Temperature Changes Fatigue Fever Headache Infections Muscular Diseases Musculoskeletal Diseases Musculoskeletal Pain Myalgia Nasal Obstruction Nervous System Diseases Neurologic Manifestations Neuromuscular Diseases Nose Diseases Otorhinolaryngologic Diseases Pain Pathological Conditions, Signs and Symptoms Pharyngeal Diseases Pharyngitis Respiration Disorders Respiratory Insufficiency Respiratory Tract Diseases Respiratory Tract Infections Signs and Symptoms Signs and Symptoms, Respiratory Sore Throat Stomatognathic Diseases

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Alabama at Birmingham, Birmingham, Alabama, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

Sensitivity and specificity for drug resistance detection

Time frame: approximately 12 months after the study is completed.

Interim results may be assessed after the first year study.

Secondary outcomes

Sensitivity and Specificity of the Test for Influenza Diagnosis

Time frame: 12 months after the study is completed.

Results may be assessed after the first year study.

Sponsors and collaborators

Lead sponsor

Cellex, Inc.

Industry

Collaborators

National Institute of Allergy and Infectious Diseases (NIAID)

Registry information

Acronym: QFlu

Important dates

Study start: 2010
Primary completion: 2012
Study completion: 2012
First posted: Jan 10, 2012
Registry last updated: Aug 6, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed