Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)

Study Overview
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Brief Summary
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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)

Official Title
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A Multi-center, Prospective, Validation Study to Assess the Accuracy of a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Adult Patients With Lower Respiratory Tract Infections

Conditions
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Lower Respiratory Tract Infection, Acute Bronchitis, Pneumonia, Chronic Obstructive Pulmonary Disease (COPD), Upper Respiratory Tract Infection

Participation Criteria
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Eligibility Criteria
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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: Peak measured (not tactile, self-reported acceptable) temperature ≥ 37.8°C (100°F) within the last 7 days (AND) Symptoms duration ≤7 days (AND) Clinical suspicion of LRTI or pneumonia 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: Use of high dose steroids >1 mg/kg/day prednisone or equivalent in the past two weeks Monoclonal antibodies Intravenous immunoglobulin (IVIG) Cyclosporine, Cyclophosphamide, Tacrolimus Granulocyte/Monocyte colony stimulating factor (G/GM-CSF) Anti-Tumor Necrosis Factor (TNF) agents Interferon (of all kinds) Other severe illnesses that affect life expectancy and quality of life such as: Moderate to severe psychomotor retardation Post-transplant patients (including solid organs, allogeneic/autologous stem cell transplantation) Moderate to severe congenital metabolic disorder

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| LRTI patients<br>Patients with suspicion of LRTI, excluding episodes of COPD exacerbations | |
| Non-infectious patients<br>Afebrile patients with no apparent infectious disease | |
| LRTI patients with COPD<br>Patients with suspicion of LRTI in a sub-group of patients with COPD | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpert™, 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To compare the diagnostic accuracy of ImmunoXpert™ 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 ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis |  | 0-6 days after the initiation of symptoms | 
| To estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™ compared to current practice |  | 0-6 days after the initiation of symptoms | 
| To estimate the diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients |  | 0-6 days after the initiation of symptoms |