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

Acute Infection Clinical Trial

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05439551
• Other study ID #: MMD012WB
• Status: Completed
• Start date: February 11, 2022
• Est. completion date: September 29, 2023

Study information

• Verified date: June 2022
• Source: MeMed Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 215
• Est. completion date: September 29, 2023
• Est. primary completion date: November 13, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 90 Days and older

Eligibility

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.

Related Conditions & MeSH terms

• Acute Infection

Intervention

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.

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Carmel Medical Center	Haifa
Israel	Sourasky Medical Center - Ichilov	Tel Aviv
United States	Maimonides Medical Center	Brooklyn	New York
United States	Urgent Care Clinical Trials @ AFC Urgent Care- Easley	Easley	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MeMed Diagnostics Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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