Clinical Evaluation of QFlu Combo Test
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Purpose
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 |
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Cough Myalgia Nasal Obstruction Sore Throat Headache Fatigue Fever |
| Study Type: | Observational |
| Study Design: | Time Perspective: Prospective |
| Official Title: | Clinical Evaluation of QFlu Combo Test |
- Sensitivity and specificity for drug resistance detection [ Time Frame: approximately 12 months after the study is completed. ] [ Designated as safety issue: No ]Interim results may be assessed after the first year study.
- Sensitivity and Specificity of the Test for Influenza Diagnosis [ Time Frame: 12 months after the study is completed. ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 1000 |
| Study Start Date: | November 2010 |
| Estimated Study Completion Date: | July 2012 |
| Estimated Primary Completion Date: | May 2012 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
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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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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.
Eligibility| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Non-Probability Sample |
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| 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 | |
More Information
No publications provided
| Responsible Party: | Cellex, Inc. |
| ClinicalTrials.gov Identifier: | NCT01506583 History of Changes |
| Other Study ID Numbers: | Cellex002, 2R44AI082728-02 |
| Study First Received: | January 6, 2012 |
| Last Updated: | January 9, 2012 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Cellex, Inc.:
|
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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Pharyngitis Cough Fatigue Headache Nasal Obstruction Respiration Disorders Respiratory Tract Diseases Signs and Symptoms, Respiratory Signs and Symptoms Pain |
Neurologic Manifestations Nervous System Diseases Nose Diseases Airway Obstruction Respiratory Insufficiency Otorhinolaryngologic Diseases Pharyngeal Diseases Stomatognathic Diseases Respiratory Tract Infections |
ClinicalTrials.gov processed this record on May 23, 2013