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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

583 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-03-10

Study Completion Date

2020-01-07

Brief Summary

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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)

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Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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LRTI patients

Patients with suspicion of LRTI, excluding episodes of COPD exacerbations

No interventions assigned to this group

Non-infectious patients

Afebrile patients with no apparent infectious disease

No interventions assigned to this group

LRTI patients with COPD

Patients with suspicion of LRTI in a sub-group of patients with COPD

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes