Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform (Perseverance Study)

A Prospective Multi-center Sample Collection Study for Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform ("Perseverance" Study)

This is a Prospective, multi-center, sample collection study enrolling pediatric and adult subjects presented to the ED/Urgent care, with symptoms consistent with acute bacterial or viral infection will be recruited according to eligibility criteria. The study is designed to measure the MeMed BV®️ score in whole blood and serum samples and demonstrate the equivalence between the two matrices. Patients will be managed according to the current standard of care per standard institutional procedures.

Study Overview

• Status: Completed
• Conditions: Acute Infection
• Intervention / Treatment: Diagnostic test: MeMed BV®

• Study Type: Observational
• Enrollment (Actual): 215

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel
    • Hillel Yaffe Medical Center
  • Haifa, Israel
    • Carmel Medical Center
  • Tel Aviv, Israel
    • Sourasky Medical Center - Ichilov
• United States
  • New York
    • Brooklyn, New York, United States, 11219
      • Maimonides Medical Center
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • Urgent Care Clinical Trials @ AFC Urgent Care- Easley

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

ED, Hospital admitted, and urgent care center patients over the age of 90 days, with clinical suspicion of acute bacterial or viral infection.

Description

Inclusion Criteria:

1. Written informed consent must be obtained from the patient or his/her legal guardian. For children under 18 years old, written informed consent from the legal guardian must be obtained and assent from the patient may be required depending on the local requirements.
2. Over 90 days of age.
3. Clinical suspicion of acute bacterial or viral infection.
4. Symptoms of acute infectious disease < 7 days.
5. Experienced fever at least once within the last 7 days (self-reported or Temperature ≥ 37.8°C (100°F)).

Exclusion Criteria:

1. HIV, HBV, active HCV, or active Tuberculosis infection (self-declared or known from medical records).
2. Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
3. Active inflammatory disease (e.g., IBD, SLE, JIA, RA, Kawasaki, other vasculitis).
4. Pregnancy- self reported or medically confirmed.
5. Active malignancy.
6. Congenital or acquired immune deficiency (CID).
7. A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen.
8. Significant trauma or burns in the last 7 days.
9. Patients that have undergone major surgery in the last 7 days.

10. Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

    1. Administration of P.O.\IV\IM high dose steroids >1mg/kg/day prednisone (or equivalent) at some point in the past 10 days or daily continuous use of steroids > 0.25 mg/kg/day in the past 7 days
    2. Monoclonal antibodies, anti-TNF agents
    3. Intravenous immunoglobulin (IVIG)
    4. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate
    5. G/GM-CSF, Interferons.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Pediatric and adults suspected of acute bacterial or viral infection; ED, Hospital admitted, and urgent care center patients over the age of 90 days, with clinical suspicion of acute bacterial or viral infection.	Diagnostic test: MeMed BV®; Patients Serum and Whole blood samples will be examined using the MeMed BV® test. Test results will have no impact on patient management.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Measuring the MeMed BV® score with whole blood and serum samples from patients suspected of acute bacterial or viral infection and demonstrating the equivalence between the two matrices.	Through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: MeMed Diagnostics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): February 11, 2022
• Primary Completion (Actual): November 13, 2022
• Study Completion (Actual): September 29, 2023

Study Registration Dates

• First Submitted: June 26, 2022
• First Submitted That Met QC Criteria: June 26, 2022
• First Posted (Actual): June 30, 2022

Study Record Updates

• Last Update Posted (Actual): October 24, 2023
• Last Update Submitted That Met QC Criteria: October 22, 2023
• Last Verified: June 1, 2022

More Information

Terms related to this study

• Other Study ID Numbers: MMD012WB

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes