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

Completed

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

• Registration Number: NCT03011515
• Lead Sponsor: MeMed Diagnostics Ltd.

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)

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-01-04
• Study First Submitted QC: 2017-01-04
• Study First Posted: 2017-01-05
• Study Start: 2017-03-10
• Primary Completion: 2018-01-01
• Study Completion: 2020-01-07
• Status Verified: 2021-10
• Last Update Submitted: 2021-10-04
• Last Update Posted: 2021-10-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 583

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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

Trial Locations

Locations (1)

Rambam Health Care Campus; 🇮🇱 Haifa, Israel