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| ID | Type | Description | Link |
|---|---|---|---|
| 2R44AI082728-02 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Allergy and Infectious Diseases (NIAID) | NIH |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and Specificity of the Test for Influenza Diagnosis | Results may be assessed after the first year study. | 12 months after the study is completed. |
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Inclusion Criteria:
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There are three population of participants: pediatric (in patient or out patient), in-patient (any age) and out-patient (any age).
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | United States | ||
| Northwestern University Feinberg School of Medicine |
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| ID | Term |
|---|---|
| D003371 | Cough |
| D063806 | Myalgia |
| D015508 | Nasal Obstruction |
| D010612 | Pharyngitis |
| D006261 | Headache |
| D005221 | Fatigue |
| D005334 | Fever |
| ID | Term |
|---|---|
| D012120 | Respiration Disorders |
| D012140 | Respiratory Tract Diseases |
| D012818 | Signs and Symptoms, Respiratory |
| D012816 | Signs and Symptoms |
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Samples were retained in case that the testing needs to be repeated. They are to be discarded 12 months after the study is completed.
| Chicago |
| Illinois |
| 61611 |
| United States |
| University of Maryland School of Medicine | Baltimore | Maryland | 21201 | United States |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D059352 | Musculoskeletal Pain |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
| D009668 | Nose Diseases |
| D000402 | Airway Obstruction |
| D012131 | Respiratory Insufficiency |
| D010038 | Otorhinolaryngologic Diseases |
| D012141 | Respiratory Tract Infections |
| D007239 | Infections |
| D010608 | Pharyngeal Diseases |
| D009057 | Stomatognathic Diseases |
| D001832 | Body Temperature Changes |