Clinical trial NCT03011515: Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)
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
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Lower Respiratory Tract Infection
Acute Bronchitis
Pneumonia
Chronic Obstructive Pulmonary Disease (COPD)
Upper Respiratory Tract Infection
Lead sponsor: MeMed Diagnostics Ltd.
Sponsor class: INDUSTRY
Collaborators: name: Rambam Health Care Campus
name: Carmel Medical Center
name: Rabin Medical Center
name: European Commission
First posted: 2017-01-05
Enrollment: 583
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: The study population will include eligible patients aged 18 years and older of both genders that attend the emergency department or affiliated community clinics due to a suspected LRTI, or due to a non-infectious disease.

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)


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)
  * 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

Primary outcomes:
measure: 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
timeFrame: 0-6 days after the initiation of symptoms
Secondary outcomes:
measure: To compare the diagnostic accuracy of ImmunoXpert™ to currently available lab measures (WBC, ANC, PCT, CRP), using sensitivity and specificity measures and predetermined cutoffs
timeFrame: 0-6 days after the initiation of symptoms
measure: To compare ImmunoXpert™ results with the physician suspected diagnosis at time of patient recruitment and compared to the reference standard diagnosis
timeFrame: 0-6 days after the initiation of symptoms
measure: To estimate the potential improvement in health and economic outcomes following the usage of ImmunoXpert™ compared to current practice
timeFrame: 0-6 days after the initiation of symptoms
measure: To estimate the diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients
timeFrame: 0-6 days after the initiation of symptoms
Other outcomes:
Locations:
city: Haifa
country: Israel
facility: Rambam Health Care Campus
Study officials:
affiliation: Rambam Health Care Campus
name: Mical Paul, MD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.