Clinical Evaluation of QFlu Combo Test

NCT01506583 | Completed

• 2 other identifiers: Cellex0022R44AI082728-02
• Study Type: observational
• Target: 506
• Locations: 1 country
• Sites: 3

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.

Conditions

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

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.

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Sensitivity and Specificity of the Test for Influenza Diagnosis

  12 months after the study is completed.

Study Arms (3)

General population

This group of participants is primarily an out-patient population.

In-patient population

This group of participants is primarily an in-patient population.

Pediatric Group

Participants in this group are children 18 years or younger.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

There are three population of participants: pediatric (in patient or out patient), in-patient (any age) and out-patient (any age).

You may qualify if:

• Those who exhibit flu-like symptom(s) during a flu season and who (or whose guardians) are willing to participate in the study.

Sponsors & Collaborators

• Cellex, Inc.: lead
• National Institute of Allergy and Infectious Diseases (NIAID): collaborator

Study Sites (3)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Northwestern University Feinberg School of Medicine

Chicago, Illinois, 61611, United States

Location

University of Maryland School of Medicine

Baltimore, Maryland, 21201, United States

Location

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.

MeSH Terms

Conditions

Cough; Myalgia; Nasal Obstruction; Pharyngitis; Headache; Fatigue; Fever

Condition Hierarchy (Ancestors)

Respiration Disorders; Respiratory Tract Diseases; Signs and Symptoms, Respiratory; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Muscular Diseases; Musculoskeletal Diseases; Neuromuscular Diseases; Nervous System Diseases; Musculoskeletal Pain; Pain; Neurologic Manifestations; Nose Diseases; Airway Obstruction; Respiratory Insufficiency; Otorhinolaryngologic Diseases; Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Body Temperature Changes

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2012
• First Posted: January 10, 2012
• Study Start: November 1, 2010
• Primary Completion: May 31, 2012
• Study Completion: May 31, 2012
• Last Updated: August 6, 2021

Record last verified: 2021-08

Locations

US (3)