CompletedNCT03011515OBSERVERUpdated Oct 12, 2021

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

An observational study in Lower Respiratory Tract Infection, Acute Bronchitis and Pneumonia, sponsored by MeMed Diagnostics Ltd.. Completed at 1 site in Israel. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2021-10-12.

Sponsored by MeMed Diagnostics Ltd. · Observational

Study type: Observational
Model: Cohort
Time perspective: Prospective
Enrollment: 583
Ages: 18 Years and older
Sex: All

Study 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 studied

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

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Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: Yes
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.

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

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

Observational model: Cohort
Time perspective: Prospective
Enrollment: 583 participants (actual)
Patient registry: No
Biospecimen retention: Samples without dna

Groups and cohorts

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

What researchers measure

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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 0-6 days after the initiation of symptoms
To estimate the diagnostic accuracy of ImmunoXpert™ in differentiating between infectious vs non-infectious patients
Time frame: 0-6 days after the initiation of symptoms

Study locations

1 site

Rambam Health Care Campus
Haifa, 3109601, Israel

References and documents

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. PubMed 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. PubMed 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. PubMed 28012942 ↗

Registry details

Key details

Study ID: NCT03011515
Lead sponsor: MeMed Diagnostics Ltd.
Collaborators: Rambam Health Care Campus, Carmel Medical Center, Rabin Medical Center, European Commission
Responsible party: Sponsor
First posted: Jan 5, 2017
Start date: Mar 10, 2017
Primary completion: Jan 1, 2018
Completion: Jan 7, 2020
Last update: Oct 12, 2021

Study contacts

Mical Paul, MD

principal investigator · Rambam Health Care Campus

Oversight

Data monitoring committee: No

View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Oct 2021. You cannot join it, but the record below documents what was studied.

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