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

Active, not recruiting

• Conditions: Sepsis; Acute Infection

• Registration Number: NCT06665542
• Lead Sponsor: MeMed Diagnostics Ltd.

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.

Study Timeline

• Study Start: 2020-11-12
• Status Verified: 2024-10
• Study First Submitted: 2024-10-28
• Study First Submitted QC: 2024-10-28
• Last Update Submitted: 2024-10-28
• Study First Posted: 2024-10-30
• Last Update Posted: 2024-10-30
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 2000

Inclusion Criteria

Not provided

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Primary objective	3,14 and 28 Days	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.

Trial Locations

Locations (8)

Maimonides MC; 🇺🇸 New York, New York, United States

MCW; 🇺🇸 Milwaukee, Wisconsin, United States

Carmel MC; 🇮🇱 Haifa, Israel

Rambam MC; 🇮🇱 Haifa, Israel

Edith Wolfson MC; 🇮🇱 H̱olon, Israel

Shaare Zedek MC; 🇮🇱 Jerusalem, Israel

Beilinson MC; 🇮🇱 Pethah Tiqvā, Israel

Sheba Tel-HaShomer MC; 🇮🇱 Tel Aviv, Israel