Evaluating the Analytical Equivalency of Serum and Whole... | NCT05439551

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

NCT05439551

Sponsor

MeMed Diagnostics Ltd.

Status

Completed

Last Update Posted

Oct 24, 2023Actual

Enrollment

215Actual

Phase

Not provided

Conditions

Acute Infection

Interventions

MeMed BV®

Countries

United States
Israel

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jun 2022

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 11, 2022Actual

Primary Completion Date

Nov 13, 2022Actual

Completion Date

Sep 29, 2023Actual

First Submitted Date

Jun 26, 2022

First Submission Date that Met QC Criteria

Jun 26, 2022

First Posted Date

Jun 30, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Oct 22, 2023

Last Update Posted Date

Oct 24, 2023Actual

Description Module

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 provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

215Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
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

Measure	Description	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

Eligibility Module

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:
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.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

90 Days

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

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.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Maimonides Medical Center		Brooklyn	New York	11219	United States
Urgent Care Clinical Trials @ AFC Urgent Care- Easley