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This is an observational prospective study of an in-vitro diagnostic (IVD) assay planned to enroll 632 subjects. The study will be conducted in two stages: Stage A is aimed at identifying individual biomarkers and constructing a multi-parametric diagnostic model, whereas Stage B is aimed at testing the multi-parametric diagnostic model using a fresh cohort of patients.
A collection of clinical, radiological and laboratory data will be gathered in order to establish a final diagnosis. Blood samples will be analyzed and the levels of approximately 700 and 250,000 biomarkers will be determined using immunoassays and molecular measurements respectively.
A final diagnosis will be determined based on a majority decision of a panel of three or more independent physicians. Based on the final diagnosis, the accuracy of individual biomarkers and combined sets of biomarkers for differentiating between distinct groups of patients will be evaluated.
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| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity and specificity of a multi-parametric diagnostic assay in differentiating between bacterial and viral etiology in patients with an acute infectious disease | We will evaluate the sensitivity and specificity of a multi-parametric diagnostic model, incorporating up to five different blood bio-markers in differentiating between bacterial and viral etiology in patients with an acute infectious disease. | 0-10 days after the initiation of symptoms |
| Measure | Description | Time Frame |
|---|---|---|
| The sensitivity and specificity of individual biomarkers in differentiating between bacterial and viral etiology in patients with an acute infectious disease | We will evaluate the sensitivity and specificity of individual bio-markers in differentiating between bacterial and viral etiology in patients with an acute infectious disease. | 0-10 days after the initiation of symptoms |
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Inclusion Criteria:
Patients who are at least one month old and are willing (either the subject or his legal guardian) to sign an informed consent will be eligible for inclusion. For the infectious and non-infectious disease groups, additional inclusion criteria have to be met. These will include:
In the Infectious disease group:
In the Non-infectious disease control group:
- A non-infectious disease or healthy individuals
Exclusion Criteria:
Patients who will meet one or more of the following criteria will be excluded from the study:
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Eligible subjects aged one month of age and older from both genders that attend the hospital or the emergency room (ER) due to a suspected acute infectious disease or due to a non-infectious disease (e.g. Trauma).
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| Name | Affiliation | Role |
|---|---|---|
| Kfir Oved, Dr. | MeMed Diagnostics Ltd. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hillel Yaffe Hospital | Hadera | Israel | 38100 | Israel | ||
| Bnei Zion Hospital |
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| ID | Term |
|---|---|
| D005759 | Gastroenteritis |
| D014115 | Toxemia |
| ID | Term |
|---|---|
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D007239 | Infections |
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Blood samples Nasopharyngeal samples
| The sensitivity and specificity of a multi-parametric assay in differentiating between mixed (bacterial and viral co-infection) and pure viral infections in patients with an acute infectious disease | We will evaluate the sensitivity and specificity of a multi-parametric diagnostic assay incorporating up to five different blood bio-markers, in differentiating between mixed infection(bacterial and viral co-infection) and pure viral infection in patients with an acute infectious disease. | 0-10 days after the initiation of symptoms |
| Haifa |
| Israel |
| 31048 |
| Israel |