Bacterial Infections Clinical Trial
— RadicalOfficial title:
Evaluation of a Rapid Diagnostic Test for the Categorization of Acute Respiratory Illness
Verified date | May 2020 |
Source | Duke University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
The primary purpose of this study is to support the development of a host response test for
acute respiratory illness to identify bacterial, viral or NB/NV etiologies as compared to a
clinical adjudication reference standard.
Secondary objectives include:
1. Evaluate the effect of age on the performance of the HR-ARI test
2. Evaluate the effect of race/ethnicity on the performance of the HR-ARI test
3. Evaluate the effect of geography on the performance of the HR-ARI test
Status | Completed |
Enrollment | 783 |
Est. completion date | December 19, 2019 |
Est. primary completion date | September 6, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 2 Years and older |
Eligibility |
Inclusion Criteria: A. Age 24 months or older B. Acute respiratory illness of less than 28 days in duration. C. Acute respiratory illness will be defined by at least two qualifying symptoms OR one qualifying symptom and at least 1 qualifying vital sign abnormality: - Qualifying symptoms:Headache, rhinorrhea, nasal congestion, sneezing, sore throat, itchy or watery eyes, conjunctivitis, cough, shortness of breath, sputum production, chest pain, wheezing - Qualifying Vital Signs: Age greater than or equal to 2 and less than 6:Tachycardia (HR greater than or equal to 110), Tachynpnea (RR greater than or equal to 20),Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. Age greater than or equal to 6: Tachycardia(HR greater than or equal to 90), Tachynpnea (RR greater than or equal to 20), Temperature greater than or equal to 38.5 degrees Celsius or less than or equal to 36 degrees Celsius. D. Ability of the subject or legally authorized representative/parent to understand study procedures, and willing and able to comply with all required. Exclusion Criteria: A. Known or suspected infection at any other anatomic site requiring antibacterial therapy. B. Any specific condition that in the judgment of the referring provider or the site investigator precludes participation because it could affect subject safety or ability of subject to participate in this trial. |
Country | Name | City | State |
---|---|---|---|
United States | Brigham and Women's Hospital | Boston | Massachusetts |
United States | The University of North Carolina at Chapel Hill | Chapel Hill | North Carolina |
United States | The University of California- Davis | Davis | California |
United States | Henry Ford Hospital | Detroit | Michigan |
United States | Duke University Medical Center | Durham | North Carolina |
United States | The University of Texas- Houston | Houston | Texas |
United States | Newton-Wellesley Hospital | Newton | Massachusetts |
United States | Children's Hospital of Pittsburgh | Pittsburgh | Pennsylvania |
United States | Rhode Island/Lifespan | Providence | Rhode Island |
United States | University of Utah Medical Center | Salt Lake City | Utah |
Lead Sponsor | Collaborator |
---|---|
Duke University | Antibacterial Resistance Leadership Group |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Positive predictive value with reference standard (PPV) | Number of assay positives that agree with the reference standard / [Number of assay positives that agree with the reference standard + Number of assay positives that disagree with the reference standard] | Day 1 | |
Primary | Negative predictive value with the reference standard (NPV) | Number of assay negatives that agree with the reference standard / [number of assay negatives that agree with the reference standard + number of assay negatives that disagree with the reference standard] | Day 1 | |
Secondary | Overall agreement with the reference standard (OA) | Number of samples that agree with the reference standard / all samples tested | Day 1 |
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