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Clinical Evaluation of QFlu Combo Test (QFlu)

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ClinicalTrials.gov Identifier: NCT01506583
Recruitment Status : Unknown
Verified January 2012 by Cellex, Inc..
Recruitment status was:  Recruiting
First Posted : January 10, 2012
Last Update Posted : January 10, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease
Cough Myalgia Nasal Obstruction Sore Throat Headache Fatigue Fever

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 Design

Study Type : Observational
Estimated Enrollment : 1000 participants
Time Perspective: Prospective
Official Title: Clinical Evaluation of QFlu Combo Test
Study Start Date : November 2010
Estimated Primary Completion Date : May 2012
Estimated Study Completion Date : July 2012
Groups and Cohorts

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.

Outcome Measures

Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.

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.

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01506583

United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35294
Contact: David Kimberlin, M.D.    205-934-5316    dkimberlin@peds.uab.edu   
Contact: Dusty Giles, R.N.    205-934-7807    dgiles@peds.uab.edu   
Principal Investigator: David Kimberlin, M.D.         
United States, Illinois
Northwestern University Feinberg School of Medicine Recruiting
Chicago, Illinois, United States, 61611
Contact: Mike Ison, M.S., M.D.    312-695-4186    mgison@northwestern.edu   
Principal Investigator: Mike Ison, M.S., M.D.         
United States, Maryland
University of Maryland School of Medicine Completed
Baltimore, Maryland, United States, 21201
Sponsors and Collaborators
Cellex, Inc.
National Institute of Allergy and Infectious Diseases (NIAID)
More Information

Responsible Party: Cellex, Inc.
ClinicalTrials.gov Identifier: NCT01506583     History of Changes
Other Study ID Numbers: Cellex002
2R44AI082728-02 ( U.S. NIH Grant/Contract )
First Posted: January 10, 2012    Key Record Dates
Last Update Posted: January 10, 2012
Last Verified: January 2012

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

Additional relevant MeSH terms:
Nasal Obstruction
Signs and Symptoms
Neurologic Manifestations
Nervous System Diseases
Pharyngeal Diseases
Stomatognathic Diseases
Respiratory Tract Infections
Respiratory Tract Diseases
Otorhinolaryngologic Diseases
Muscular Diseases
Musculoskeletal Diseases
Musculoskeletal Pain
Neuromuscular Diseases
Nose Diseases
Airway Obstruction
Respiratory Insufficiency
Respiration Disorders