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The study is a multi-center, prospective, observational clinical study enrolling patients from at least 3 medical centers. Study population will include patients over the age of 18 years.
The study will recruit patients presenting with suspicion of acute infection/sepsis and healthy individuals.
Study main objective is to derive and verify a host response based score to predicte severe outcome.
For determining disease severity each enrolled patient will be assigned as either "severe outcome patient" or "non severe outcome patient" according to predefined criteria. (or "healthy").
Participation in the study requires the collection of routine patient data and blood sample. Blood samples will be used for measurements of host biomarkers that predict disease severity. The blood samples will be collected upon enrollment.
In addition, a standardized patient questionnaire inquiring about severity outcomes met up to 28 days after presentation will be conducted by phone call 28 to 42 days post admission.
Enrolled patients will be managed according to the current standard of care per standard institutional procedures. Results of the measured biomarkers will not be revealed to the attending clinician and so will not influence patient management.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Suspected infection/sepsis | Patient presenting with a clinical suspicion of acute infection/sepsis as defined by the attending physician, based on clinical presentation. | ||
| Healthy Individuals | No clinical suspicion of acute infection. |
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| Measure | Description | Time Frame |
|---|---|---|
| Primary objective | To derive and verify the diagnostic performance of a host-response tool based on novel biomarkers for predicting disease severity in adult patients, aged 18 years or older, presenting with clinical suspicion of acute infection/sepsis. | 3,14 and 28 Days |
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Suspected acute infection/sepsis patients
Patients eligible for inclusion are required to fulfill all of the following criteria:
Healthy individuals
Patients eligible for inclusion are required to fulfill all of the following criteria:
Exclusion Criteria:
Suspected acute infection/sepsis patients
Patients fulfilling the following criteria are not eligible for inclusion in this study:
Patients fulfilling the following criteria are not eligible for inclusion in this study:
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patients presenting with suspected infection/sepsis as defined by the attending physician, based on clinical presentation and laboratory/radiological findings. Additionally, the study will recruit healthy individuals across all study sites.
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maimonides MC | New York | New York | 11219 | United States | ||
| MCW |
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| Label | URL |
|---|---|
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Plasma , Serum , whole Blood
| Milwaukee |
| Wisconsin |
| 53226 |
| United States |
| Carmel MC | Haifa | 3436212 | Israel |
| Rambam MC | Haifa | 3902908 | Israel |
| Edith Wolfson MC | Holon | 2240832 | Israel |
| Shaare Zedek MC | Jerusalem | 93722 | Israel |
| Beilinson MC | Petah Tikva | 4649275 | Israel |
| Sheba Tel-HaShomer MC | Tel Aviv | 52621 | Israel |
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| ID | Term |
|---|---|
| D018805 | Sepsis |
| D012772 | Shock, Septic |
| ID | Term |
|---|---|
| D007239 | Infections |
| D018746 | Systemic Inflammatory Response Syndrome |
| D007249 | Inflammation |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012769 | Shock |
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