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| Name | Class |
|---|---|
| Rambam Health Care Campus | OTHER |
| Carmel Medical Center | OTHER |
| Rabin Medical Center | OTHER |
| European Commission |
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The purpose of this study is to validate the diagnostic accuracy of a novel host-response based diagnostic tool for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of lower respiratory tract infections (LRTI)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| LRTI patients | Patients with suspicion of LRTI, excluding episodes of COPD exacerbations | ||
| Non-infectious patients | Afebrile patients with no apparent infectious disease | ||
| LRTI patients with COPD | Patients with suspicion of LRTI in a sub-group of patients with COPD |
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| Measure | Description | Time Frame |
|---|---|---|
| To externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpertâ„¢, for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of LRTI | 0-6 days after the initiation of symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| To compare the diagnostic accuracy of ImmunoXpertâ„¢ to currently available lab measures (WBC, ANC, PCT, CRP), using sensitivity and specificity measures and predetermined cutoffs | 0-6 days after the initiation of symptoms | |
| To compare ImmunoXpertâ„¢ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis |
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Inclusion Criteria:
Patients aged 18 years and older who agree (or their legal guardian agree) to sign an informed consent will be eligible for inclusion.
The LRTI cohorts should also fulfill the following criteria:
Exclusion Criteria:
Oral/intravenous/intramuscular antibiotic treatment of over 48/12/12 hours' duration at time of enrollment (respectively), unless temperature ≥ 37.8°C was measured within the last 2 days
Another episode of an acute infection during the last 2 weeks
Congenital immune deficiency (CID)
A proven or suspected human immunodeficiency virus (HIV)-1, hepatitis B virus (HBV), or hepatitis C virus (HCV) infection
Active malignancy
Pregnancy
Current treatment with immune-suppressive or immune-modulating therapies including without limitations:
Other severe illnesses that affect life expectancy and quality of life such as:
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The study population will include eligible patients aged 18 years and older of both genders that attend the emergency department or affiliated community clinics due to a suspected LRTI, or due to a non-infectious disease.
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| Name | Affiliation | Role |
|---|---|---|
| Mical Paul, MD | Rambam Health Care Campus | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rambam Health Care Campus | Haifa | 3109601 | Israel |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25785720 | Background | Oved K, Cohen A, Boico O, Navon R, Friedman T, Etshtein L, Kriger O, Bamberger E, Fonar Y, Yacobov R, Wolchinsky R, Denkberg G, Dotan Y, Hochberg A, Reiter Y, Grupper M, Srugo I, Feigin P, Gorfine M, Chistyakov I, Dagan R, Klein A, Potasman I, Eden E. A novel host-proteome signature for distinguishing between acute bacterial and viral infections. PLoS One. 2015 Mar 18;10(3):e0120012. doi: 10.1371/journal.pone.0120012. eCollection 2015. | |
| 27255416 |
| Label | URL |
|---|---|
| Related Info | View source |
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| OTHER |
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Venous blood and nasal swab
| 0-6 days after the initiation of symptoms |
| To estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpertâ„¢ compared to current practice | 0-6 days after the initiation of symptoms |
| To estimate the diagnostic accuracy of ImmunoXpertâ„¢ in differentiating between infectious vs non-infectious patients | 0-6 days after the initiation of symptoms |
| Background |
| Eden E, Srugo I, Gottlieb T, Navon R, Boico O, Cohen A, Bamberger E, Klein A, Oved K. Diagnostic accuracy of a TRAIL, IP-10 and CRP combination for discriminating bacterial and viral etiologies at the Emergency Department. J Infect. 2016 Aug;73(2):177-80. doi: 10.1016/j.jinf.2016.05.002. Epub 2016 May 30. No abstract available. |
| 28012942 | Background | van Houten CB, de Groot JAH, Klein A, Srugo I, Chistyakov I, de Waal W, Meijssen CB, Avis W, Wolfs TFW, Shachor-Meyouhas Y, Stein M, Sanders EAM, Bont LJ. A host-protein based assay to differentiate between bacterial and viral infections in preschool children (OPPORTUNITY): a double-blind, multicentre, validation study. Lancet Infect Dis. 2017 Apr;17(4):431-440. doi: 10.1016/S1473-3099(16)30519-9. Epub 2016 Dec 22. |
| ID | Term |
|---|---|
| D001991 | Bronchitis |
| D011014 | Pneumonia |
| D029424 | Pulmonary Disease, Chronic Obstructive |
| D012141 | Respiratory Tract Infections |
| ID | Term |
|---|---|
| D007239 | Infections |
| D001982 | Bronchial Diseases |
| D012140 | Respiratory Tract Diseases |
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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