FebriDx Evaluation for Acute Community Acquired Febrile Upper Respiratory Infection
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Infectious Disease, Pulmonary |
| Therapuetic Areas: | Immunology / Infectious Diseases, Pulmonary / Respiratory Diseases |
| Healthy: | No |
| Age Range: | 1 - Any |
| Updated: | 10/5/2017 |
| Start Date: | November 2013 |
| End Date: | August 2020 |
Clinical Performance of FebriDx in Patients Being Evaluated for Acute Community Acquired Febrile Respiratory Infection
The purpose of this study is to investigate FebriDx, a point-of-care, non-invasive, rapid
diagnostic test, at identifying an immune response to viral and bacterial infection related
to an acute community acquired febrile upper respiratory infection, as compared to expert
clinical reviewers' evaluation in conjunction with the results of clinical standardized
microbiologic and laboratory testing.
diagnostic test, at identifying an immune response to viral and bacterial infection related
to an acute community acquired febrile upper respiratory infection, as compared to expert
clinical reviewers' evaluation in conjunction with the results of clinical standardized
microbiologic and laboratory testing.
URI ARM INCLUSION CRITERIA
- 1 years of age or older
- Exhibit or report temperature (oral or tympanic) of greater than or equal to 100.5°F
within 3 days (72 hours) of enrollment
- Presents with at least one of the following symptoms: runny nose, nasal congestion,
sore throat, cough, hoarse voice or shortness of breath beginning no earlier than 7
days before enrollment
URI ARM EXCLUSION CRITERIA
- Suspected of having lower respiratory infection (other than acute bronchitis)
- Receiving interferon therapy (e.g. MS, HIV, HBV, HCV) in the last 30 days
- Immunocompromised state (e.g. HIV) or taking immunosuppressive or chemotherapeutic
medications in the last 30 days
- Taking antibiotics or antiviral therapy in the last 30 days
- Received a live viral immunization in the last 30 days
- Significant trauma or burns (> 5% total body surface area or full thickness (3rd°)) in
the last 30 days
- Major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the
last 30 days
- Chronic fever greater than 7 days
- Suspected of having otitis media
ASYMPTOMATIC ARM INCLUSION CRITERIA
- 2 years of age or older
- Asymptomatic for a noninfectious illness who present to primary care and urgent care
outpatient offices and emergency departments
ASYMPTOMATIC ARM EXCLUSION CRITERIA
- Fever greater than or equal to 100.5°F (oral or tympanic) in last 14 days
- Cough
- Chills
- Dyspnea
- Nasal congestion
- Rhinorrhea
- Sore throat
- Hoarse voice
- Autoimmune or rheumatologic disease
- Suspected of having lower respiratory infection (other than acute bronchitis)
- Receiving interferon therapy (eg. MS, HIV, HBV, HCV) in last 30 days
- Immunocompromised state (eg. HIV) or taking immunosuppressive or chemotherapeutic
medications in the last 30 days
- Taking antibiotics or antiviral therapy in the last 30 days
- Received a live viral immunization in the last 30 days
- Significant trauma or burns (> 5% total body surface area or full thickness (3rd°)) in
the last 30 days
- Major surgery (requiring intravenous anesthesia and/or respiratory assistance) in the
last 30 days
- History of a myocardial infarction or stroke in the last 30 days
- Chronic bacterial infection or osteomyelitis
- Known chronic viral infections such as HIV, HCV, HBV, or CMV
- Active tuberculosis
- Acute or chronic (greater than 30 days) diarrhea and/or vomiting
- Urinary tract symptoms in the last 14 days
- Active skin, ocular, or neurologic infections
- Suspected of having otitis media
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Brigham and Women's Hosp Boston’s Brigham and Women’s Hospital (BWH) is an international leader in...
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Beth Israel Deaconess Medical Center Beth Israel Deaconess Medical Center (BIDMC) is one of the...
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New York Methodist Hospital A voluntary, acute-care teaching hospital, New York Methodist Hospital's mission is...
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