A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-resp… (NCT06665542) | Clinical Trial Compass
Active — Not RecruitingNot Applicable
A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.
United States, Israel2,000 participantsStarted 2020-11-12
Plain-language summary
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.
Who can participate
Age range18 Years
SexALL
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Suspected acute infection/sepsis patients
Patients eligible for inclusion are required to fulfill all of the following criteria:
* Written informed consent must be obtained from the patient or his/her legal guardian.
* Over 18 years of age
* Clinical suspicion of acute infection/sepsis as defined by the attending physician, based on clinical presentation.
Healthy individuals
Patients eligible for inclusion are required to fulfill all of the following criteria:
* Written informed consent must be obtained from the patient
* Over 18 years of age
* No clinical suspicion of acute infection.
Exclusion Criteria:
Suspected acute infection/sepsis patients
Patients fulfilling the following criteria are not eligible for inclusion in this study:
* HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records).
* Pregnancy- self reported or medically confirmed. Healthy individuals
Patients fulfilling the following criteria are not eligible for inclusion in this study:
* Episode of infection in the last 2 weeks
* Major trauma and\\or burns and\\or surgery in the last 2 weeks
* HIV, HBV, active HCV or active Tuberculosis infection (self-declared or known from medical records)
* Elective surgery patients
* Pregnancy- self reported or medically confirmed