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

NCT03011515 — Completed, 583 participants, MeMed Diagnostics Ltd.

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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

Registry	NCT03011515, acronym OBSERVER
Status	Completed
Study type	Observational
Enrollment	583 (Actual)
Sponsor	MeMed Diagnostics Ltd. (Industry); collaborators: Rambam Health Care Campus, Carmel Medical Center, Rabin Medical Center, European Commission
Conditions	Lower Respiratory Tract Infection, Acute Bronchitis, Pneumonia, Chronic Obstructive Pulmonary Disease (COPD), Upper Respiratory Tract Infection
Dates	start 2017-03-10, primary completion 2018-01-01, completion 2020-01-07, first posted 2017-01-05, last updated 2021-10-12
Locations	1 site in Israel

-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)

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+Arms and interventions

Arm	Type	Interventions	Description
LRTI patients			Patients with suspicion of LRTI, excluding episodes of COPD exacerbations
Non-infectious patients			Afebrile patients with no apparent infectious disease
LRTI patients with COPD			Patients with suspicion of LRTI in a sub-group of patients with COPD

+Outcome measures

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 [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 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]

+Eligibility

Sex: All, ages: 18 Years to any, accepts healthy volunteers

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

+Locations (1)

Facility	City	Country	Status
Rambam Health Care Campus	Haifa	Israel

+Publications

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. PMID 25785720
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. No abstract available. PMID 27255416
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. PMID 28012942

+Investigators

Mical Paul, MD, Principal investigator, Rambam Health Care Campus

My Notes

Public

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