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

MeMed Diagnostics Ltd.1 site in 1 country583 target enrollmentMarch 10, 2017

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

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Lower Respiratory Tract Infection
Sponsor: MeMed Diagnostics Ltd.
Enrollment: 583
Locations: 1
Primary Endpoint: 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
Status: Completed
Last Updated: 4 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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)

Registry

clinicaltrials.gov

Start Date

March 10, 2017

End Date

January 7, 2020

Last Updated

4 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MeMed Diagnostics Ltd.

Responsible Party

Sponsor

Eligibility Criteria

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)

Outcomes

Primary Outcomes

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

Time Frame: 0-6 days after the initiation of symptoms

Secondary Outcomes

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 diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients(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)