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

Pneumonia Clinical Trial

— OBSERVER  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03011515
• Other study ID #: MM-1005-OB
• Status: Completed
• Start date: March 10, 2017
• Est. completion date: January 7, 2020

Study information

• Verified date: October 2021
• Source: MeMed Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 583
• Est. completion date: January 7, 2020
• Est. primary completion date: January 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Acute Bronchitis
• Bronchitis
• Chronic Obstructive Pulmonary Disease (COPD)
• Communicable Diseases
• Infections
• Lower Respiratory Tract Infection
• Lung Diseases, Obstructive
• Pneumonia
• Pulmonary Disease, Chronic Obstructive
• Respiratory Tract Infections
• Upper Respiratory Tract Infection

Locations

Country	Name	City	State
Israel	Rambam Health Care Campus	Haifa

Sponsors (5)

Lead Sponsor	Collaborator
MeMed Diagnostics Ltd.	Carmel Medical Center, European Commission, Rabin Medical Center, Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	To estimate the diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients		0-6 days after the initiation of symptoms

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