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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03011515
Recruitment Status : Active, not recruiting
First Posted : January 5, 2017
Last Update Posted : August 13, 2019
Sponsor:
Collaborators:
Rambam Health Care Campus
Hannover Medical School
Royal Free Hospital NHS Foundation Trust
European Commission
Carmel Medical Center
Rabin Medical Center
Information provided by (Responsible Party):
MeMed Diagnostics Ltd.

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)

Condition or disease
Lower Respiratory Tract Infection Fungal Acute Bronchitis Pneumonia Chronic Obstructive Pulmonary Disease (COPD) Upper Respiratory Tract Infection

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Study Type : Observational
Estimated Enrollment : 1135 participants
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
Actual Study Start Date : March 10, 2017
Actual Primary Completion Date : May 1, 2019
Estimated Study Completion Date : September 2019

Group/Cohort
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



Primary Outcome Measures :
  1. 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 :
  1. 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 ]
  2. 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


Information from the National Library of Medicine

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, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 measured (not tactile, self-reported acceptable) temperature ≥ 37.8°C (100°F) within the last 2 days (AND)
    • Symptoms duration ≤7 days (AND)
    • Clinical suspicion of LRTI including pneumonia

Exclusion Criteria:

  • 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:

    • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03011515


Locations
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Israel
Rambam Health Care Campus
Haifa, Israel, 3109601
United Kingdom
University College London Hospital
London, United Kingdom, WC1E 6JF
Sponsors and Collaborators
MeMed Diagnostics Ltd.
Rambam Health Care Campus
Hannover Medical School
Royal Free Hospital NHS Foundation Trust
European Commission
Carmel Medical Center
Rabin Medical Center
Investigators
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Principal Investigator: Mical Paul, MD Rambam Health Care Campus

Additional Information:
Publications:
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Responsible Party: MeMed Diagnostics Ltd.
ClinicalTrials.gov Identifier: NCT03011515    
Other Study ID Numbers: MM-1005-OB
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: August 13, 2019
Last Verified: August 2019
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Respiratory Tract Infections
Lung Diseases, Obstructive
Pulmonary Disease, Chronic Obstructive
Pneumonia
Bronchitis
Lung Diseases
Respiratory Tract Diseases
Bronchial Diseases