An observational study in Fever, Respiratory Tract Infections and Urinary Tract Infections, sponsored by MeMed Diagnostics Ltd.. Completed at 2 sites in Israel. Open to participants aged 1 Month to 18 Years. Per ClinicalTrials.gov, last updated 2016-03-08.
Sponsored by MeMed Diagnostics Ltd. · Observational
This is a retrospective, blinded, external validation study of a novel in-vitro diagnostic (IVD) assay that will include samples that were previously collected from febrile pediatric patients. The investigated assay measures the levels of a few host-related, blood-based, bio-markers that will be integrated into a single score. Based on this score, each patient will be classified into one of three categories: (i) bacterial immune response, (ii) viral immune response, and (iii) marginal immune response. The assay prediction and the patient diagnosis will than be unveiled and compared to determine their level of concordance.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's enrollment of 600 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →MeMed Diagnostics Ltd. is the lead sponsor of 13 studies on the registry; 1 is open to participants now.
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The study population will include patients aged 1 month to 18 years of age that were sampled both during emergency department (ED) visit or during hospitalization stay and were diagnosed with an acute infectious disease or a non-infectious disease. All samples are expected to fall into one of the following categories:
The infectious disease samples should also fulfill the following criteria:
The non-infectious disease control group will include:
Exclusion Criteria:
The sensitivity and specificity of the assay in differentiating between bacterial and viral etiology of patients with an acute febrile disease
We will evaluate the assay using the accuracy measures sensitivity and specificity of differentiating between bacterial and viral etiology of pediatric patients aged 1 month to 18 years with an acute febrile disease.
Time frame: 0-7 days after the initiation of symptoms
The sensitivity and specificity of the assay in differentiating between infectious and non-infectious disease etiology.
We will evaluate the assay using the accuracy measures sensitivity and specificity of differentiating between infectious and non-infectious disease etiology in pediatric patients aged 1 month to 18 years.
Time frame: 0-7 days after the initiation of symptoms
Plan to share: No
No publications or documents are linked to this record.
This study is completed, as verified in Mar 2016. You cannot join it, but the record below documents what was studied.
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MeMed Diagnostics Ltd.