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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
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
Timeframe: 0-6 days after the initiation of symptoms