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

October 28, 2024 updated by: MeMed Diagnostics Ltd.

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.

Study Overview

Status

Active, not recruiting

Conditions

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 Type

Observational

Enrollment (Estimated)

2000

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Israel
      • Haifa, Israel, 3436212
        • Carmel MC
      • Haifa, Israel, 3902908
        • Rambam MC
      • H̱olon, Israel, 2240832
        • Edith Wolfson MC
      • Jerusalem, Israel, 93722
        • Shaare Zedek MC
      • Pethah Tiqvā, Israel, 4649275
        • Beilinson MC
      • Tel Aviv, Israel, 52621
        • Sheba Tel-HaShomer MC
  • United States
    • New York
      • New York, New York, United States, 11219
        • Maimonides MC
    • Wisconsin
      • Milwaukee, Wisconsin, United States, 53226
        • MCW

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

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.

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Suspected infection/sepsis
Patient presenting with a clinical suspicion of acute infection/sepsis as defined by the attending physician, based on clinical presentation.
Healthy Individuals
No clinical suspicion of acute infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Primary objective
Time Frame: 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.
3,14 and 28 Days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MeMed Diagnostics Ltd.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 12, 2020

Primary Completion (Estimated)

December 31, 2025

Study Completion (Estimated)

December 31, 2025

Study Registration Dates

First Submitted

October 28, 2024

First Submitted That Met QC Criteria

October 28, 2024

First Posted (Actual)

October 30, 2024

Study Record Updates

Last Update Posted (Actual)

October 30, 2024

Last Update Submitted That Met QC Criteria

October 28, 2024

Last Verified

October 1, 2024

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MMD01SEV

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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