Clinical Evaluation of QFlu Combo Test (QFlu)
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| ClinicalTrials.gov Identifier: NCT01506583 |
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Recruitment Status : Unknown
Verified January 2012 by Cellex, Inc..
Recruitment status was: Recruiting
First Posted : January 10, 2012
Last Update Posted : January 10, 2012
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Sponsor:
Cellex, Inc.
Collaborator:
National Institute of Allergy and Infectious Diseases (NIAID)
Information provided by (Responsible Party):
Cellex, Inc.
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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 |
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| Cough Myalgia Nasal Obstruction Sore Throat Headache Fatigue Fever |
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 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 |
| Group/Cohort |
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General population
This group of participants is primarily an out-patient population.
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In-patient population
This group of participants is primarily an in-patient population.
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Pediatric Group
Participants in this group are children 18 years or younger.
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Primary Outcome Measures :
- 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 :
- 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.
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| Ages Eligible for Study: | Child, Adult, Older Adult |
| 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).
Criteria
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.
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
Locations
| 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)
| 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.:
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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. |
Additional relevant MeSH terms:
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Fatigue Headache Pharyngitis Myalgia Nasal Obstruction Signs and Symptoms Pain 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 |