Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiolo… (NCT03011515) | Clinical Trial Compass
CompletedNot Applicable
Evaluating a Host-response Based Diagnostic for Distinguishing Between Bacterial and Viral Etiology in Patients With Lower Respiratory Tract Infection (LRTI)
Israel583 participantsStarted 2017-03-10
Plain-language 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)
Who can participate
Age range18 Years
SexALL
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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…
What they're measuring
1
To externally validate the diagnostic accuracy of a host-response based diagnostic tool called ImmunoXpertâ„¢, for differentiating between bacterial and viral etiologies in adult patients aged 18 years and older with clinical suspicion of LRTI
Timeframe: 0-6 days after the initiation of symptoms