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

This study is currently recruiting participants.
See Contacts and Locations
Verified January 2017 by MeMed Diagnostics Ltd.
Sponsor:
Collaborators:
Rambam Health Care Campus
Hannover Medical School
Royal Free Hospital NHS Foundation Trust
European Commission
Information provided by (Responsible Party):
MeMed Diagnostics Ltd.
ClinicalTrials.gov Identifier:
NCT03011515
First received: January 4, 2017
Last updated: April 2, 2017
Last verified: January 2017
  Purpose
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)

Condition Intervention
Lower Respiratory Tract Infection Fungal Acute Bronchitis Pneumonia Chronic Obstructive Pulmonary Disease (COPD) Upper Respiratory Tract Infection Other: Non-interventional

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
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

Further study details as provided by MeMed Diagnostics Ltd.:

Primary Outcome Measures:
  • Sensitivity and specificity of a novel host-based diagnostic in differentiating between bacterial and viral etiology for adult patients (>18 years) with suspicion of LRTI, excluding episodes of COPD exacerbations [ Time Frame: 0-6 days after the initiation of symptoms ]

Secondary Outcome Measures:
  • Sensitivity and specificity of a novel host-based diagnostic in differentiating between infectious and non-infectious disease for adult patients (>18 years) [ Time Frame: 0-6 days after the initiation of symptoms ]
  • Sensitivity and specificity of clinical and lab parameters in differentiating between bacterial and viral etiologies of adult patients (>18 years) with suspicion of LRTI, excluding episodes of COPD exacerbations [ Time Frame: 0-6 days after the initiation of symptoms ]

Biospecimen Retention:   Samples Without DNA
Venous blood and nasal swab

Estimated Enrollment: 1135
Actual Study Start Date: March 10, 2017
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: October 2018 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
LRTI patients
Patients with suspicion of LRTI, excluding episodes of COPD exacerbations
Other: Non-interventional
Non-infectious patients
Afebrile patients with no apparent infectious disease
Other: Non-interventional
LRTI patients with COPD
Patients with suspicion of LRTI in a sub-group of patients with COPD
Other: Non-interventional

  Eligibility

Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   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.
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 fever ≥37.8°C (100°F) (AND)
    • Symptoms duration ≤7 days (AND)
    • Clinical suspicion of LRTI including pneumonia

Exclusion Criteria:

  • Another episode of an acute infection during the last 3 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:

    • High dose steroids >1 mg/kg/day prednisone or equivalent
    • Monoclonal antibody administration
    • Intravenous immunoglobulin (IVIG)
    • Cyclosporine
    • 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
    • Moderate to severe congenital metabolic disorder
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT03011515

Contacts
Contact: Liran Shani, MD +972-4-8500302 liran.shani@me-med.com
Contact: Meital Paz +972-4-8500302 meital.paz@me-med.com

Locations
Israel
Rambam Health Care Campus Recruiting
Haifa, Israel, 3109601
Contact: Mical Paul, MD       M_Paul@rambam.health.gov.il   
United Kingdom
University College London Hospital Not yet recruiting
London, United Kingdom, WC1E 6JF
Contact: John Hurst, MD       j.hurst@ucl.ac.uk   
Sponsors and Collaborators
MeMed Diagnostics Ltd.
Rambam Health Care Campus
Hannover Medical School
Royal Free Hospital NHS Foundation Trust
European Commission
Investigators
Principal Investigator: Mical Paul, MD Rambam Health Care Campus
  More Information

Additional Information:
Publications:
Responsible Party: MeMed Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT03011515     History of Changes
Other Study ID Numbers: MM-1005-OB
Study First Received: January 4, 2017
Last Updated: April 2, 2017

Additional relevant MeSH terms:
Infection
Communicable Diseases
Lung Diseases
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pneumonia
Respiratory Tract Infections
Bronchitis
Mycoses
Respiratory Tract Diseases
Bronchial Diseases

ClinicalTrials.gov processed this record on June 23, 2017