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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT03011515

Acronym

OBSERVER

Enrollment

583

Registered

2017-01-05

Start date

2017-03-10

Completion date

2020-01-07

Last updated

2021-10-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Brief summary

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)

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	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

Measure	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

Countries

Israel

Outcome results