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

NCT03011515 | Completed

• 1 other identifier: MM-1005-OB
• Study Type: observational
• Target: 583
• Locations: 1 country
• Sites: 1

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)

Conditions

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

Outcome Measures

Primary Outcomes (1)

• 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 (4)

• 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

Study Arms (3)

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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:

Sponsors & Collaborators

• MeMed Diagnostics Ltd.: lead
• Rambam Health Care Campus: collaborator
• Carmel Medical Center: collaborator
• Rabin Medical Center: collaborator
• European Commission: collaborator

Study Sites (1)

Rambam Health Care Campus

Haifa, 3109601, Israel

Location

Related Publications (3)

• 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 BACKGROUND

• 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 BACKGROUND

• 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 BACKGROUND

Related Links

• Related Info

Biospecimen

Retention: SAMPLES WITHOUT DNA

Venous blood and nasal swab

MeSH Terms

Conditions

Bronchitis; Pneumonia; Pulmonary Disease, Chronic Obstructive; Respiratory Tract Infections

Condition Hierarchy (Ancestors)

Infections; Bronchial Diseases; Respiratory Tract Diseases; Lung Diseases, Obstructive; Lung Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mical Paul, MD

  Rambam Health Care Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2017
• First Posted: January 5, 2017
• Study Start: March 10, 2017
• Primary Completion: January 1, 2018
• Study Completion: January 7, 2020
• Last Updated: October 12, 2021

Record last verified: 2021-10

Locations

IL (1)