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.
Study Type
OBSERVATIONAL
Enrollment
2,000
Maimonides MC
New York, New York, United States
MCW
Milwaukee, Wisconsin, United States
Carmel MC
Haifa, Israel
Rambam MC
Haifa, Israel
Edith Wolfson MC
Holon, Israel
Shaare Zedek MC
Jerusalem, Israel
Beilinson MC
Petah Tikva, Israel
Sheba Tel-HaShomer MC
Tel Aviv, Israel
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.
Time frame: 3,14 and 28 Days
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