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

Completed

• Conditions: Acute Infection
• Interventions: Diagnostic Test: MeMed BV®

• Registration Number: NCT05439551
• Lead Sponsor: MeMed Diagnostics Ltd.

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-02-11
• Status Verified: 2022-06
• Study First Submitted: 2022-06-26
• Study First Submitted QC: 2022-06-26
• Study First Posted: 2022-06-30
• Primary Completion: 2022-11-13
• Study Completion: 2023-09-29
• Last Update Submitted: 2023-10-22
• Last Update Posted: 2023-10-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 215

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Pediatric and adults suspected of acute bacterial or viral infection	MeMed BV®	ED, Hospital admitted, and urgent care center patients over the age of 90 days, with clinical suspicion of acute bacterial or viral infection.

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (5)

Hillel Yaffe Medical Center; 🇮🇱 Hadera, Israel

Sourasky Medical Center - Ichilov; 🇮🇱 Tel Aviv, Israel

Urgent Care Clinical Trials @ AFC Urgent Care- Easley; 🇺🇸 Easley, South Carolina, United States

Carmel Medical Center; 🇮🇱 Haifa, Israel

Maimonides Medical Center; 🇺🇸 Brooklyn, New York, United States