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)

MeMed Diagnostics Ltd.5 sites in 2 countries215 target enrollmentFebruary 11, 2022

ConditionsAcute Infection

Overview

Phase: N/A
Intervention: Not specified
Conditions: Acute Infection
Sponsor: MeMed Diagnostics Ltd.
Enrollment: 215
Locations: 5
Primary Endpoint: 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.
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

February 11, 2022

End Date

September 29, 2023

Last Updated

2 years ago

Study Type

Observational

Sex

All

Investigators

Sponsor

MeMed Diagnostics Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•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)).

Exclusion Criteria

•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:

Outcomes

Primary Outcomes

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.

Time Frame: Through study completion, an average of 18 months