A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

2000 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-11-12

Study Completion Date

2025-12-31

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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Sepsis Acute Infection

Study Design

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Observational Model Type

COHORT

Study Time Perspective

OTHER

Study Groups

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Suspected infection/sepsis

Patient presenting with a clinical suspicion of acute infection/sepsis as defined by the attending physician, based on clinical presentation.

No interventions assigned to this group

Healthy Individuals

No clinical suspicion of acute infection.

No interventions assigned to this group

Eligibility Criteria

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Inclusion 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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes