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

NCT05439551 | Completed FDA Device

• 1 other identifier: MMD012WB
• Study Type: observational
• Target: 215
• Locations: 2 countries
• Sites: 5

Brief Summary

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.

Conditions

Acute Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

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®

Interventions

MeMed BV® DIAGNOSTIC_TEST

Patients Serum and Whole blood samples will be examined using the MeMed BV® test. Test results will have no impact on patient management.

Pediatric and adults suspected of acute bacterial or viral infection

Eligibility Criteria

• Age: 90 Days+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.
• Over 90 days of age.
• Clinical suspicion of acute bacterial or viral infection.
• Symptoms of acute infectious disease \< 7 days.
• Experienced fever at least once within the last 7 days (self-reported or Temperature ≥ 37.8°C (100°F)).

You may not qualify if:

• HIV, HBV, active HCV, or active Tuberculosis infection (self-declared or known from medical records).
• Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
• Active inflammatory disease (e.g., IBD, SLE, JIA, RA, Kawasaki, other vasculitis).
• Pregnancy- self reported or medically confirmed.
• Active malignancy.
• Congenital or acquired immune deficiency (CID).
• A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen.
• Significant trauma or burns in the last 7 days.
• Patients that have undergone major surgery in the last 7 days.
• Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:
• 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
• Monoclonal antibodies, anti-TNF agents
• Intravenous immunoglobulin (IVIG)
• Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate
• G/GM-CSF, Interferons.

Sponsors & Collaborators

• MeMed Diagnostics Ltd.: lead

Study Sites (5)

Maimonides Medical Center

Brooklyn, New York, 11219, United States

Location

Urgent Care Clinical Trials @ AFC Urgent Care- Easley

Easley, South Carolina, 29640, United States

Location

Hillel Yaffe Medical Center

Hadera, Israel

Location

Carmel Medical Center

Haifa, Israel

Location

Sourasky Medical Center - Ichilov

Tel Aviv, Israel

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2022
• First Posted: June 30, 2022
• Study Start: February 11, 2022
• Primary Completion: November 13, 2022
• Study Completion: September 29, 2023
• Last Updated: October 24, 2023

Record last verified: 2022-06

Data Sharing

• IPD Sharing: Will share

Locations

IL (3); US (2)