Clinical trial NCT06665542: A Multicenter Prospective Observational Study to Derive and Verify the Performance of a Host-response Based Diagnostic Tool for Early Detection of Severe Infections.
Official title: 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 type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Sepsis
Acute Infection
Keywords: Host response
Suspected sepsis
Suspected acute infection
Biomarkers
ARDS
Septic shock
Sepsis associated AKI
Lead sponsor: MeMed Diagnostics Ltd.
Sponsor class: INDUSTRY
First posted: 2024-10-30
Enrollment: 2000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: 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.

Brief 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.

Detailed description: 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.

Eligibility criteria: 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

Primary outcomes:
measure: Primary objective
timeFrame: 3,14 and 28 Days
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Maimonides MC
state: New York
city: Milwaukee
country: United States
facility: MCW
state: Wisconsin
city: Haifa
country: Israel
facility: Carmel MC
city: Haifa
country: Israel
facility: Rambam MC
city: H̱olon
country: Israel
facility: Edith Wolfson MC
city: Jerusalem
country: Israel
facility: Shaare Zedek MC
city: Pethah Tiqvā
country: Israel
facility: Beilinson MC
city: Tel Aviv
country: Israel
facility: Sheba Tel-HaShomer MC
Study officials:
References: