Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts

The purpose of the pivotal study is to collect blood specimens and clinical data from pediatric (>90 days old) and adult (≥18 years old) patients presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to establish the diagnostic performance of MeMed BV™ for differentiating bacterial from viral infection using method comparison and/or method concordance.

Study Overview

• Status: Completed
• Conditions: Infection, Bacterial; Infection Viral
• Intervention / Treatment: Other: Adult and Pediatrics

Detailed Description

The objective of this study is to collect blood specimens from pediatric (>90 days old) and adult patients (≥18 years old) presenting with signs and symptoms suggestive of acute bacterial or viral infection from hospital, Emergency Department, or Urgent Care Centers for comparative testing on the Access 2 and DxI 9000 Immunoassay Analyzers.

• Study Type: Observational
• Enrollment (Actual): 650

Contacts and Locations

Study Locations

• United States
  • Indiana
    • Indianapolis, Indiana, United States, 46202
      • Indiana University School of Medicine
  • Maryland
    • Baltimore, Maryland, United States, 21287
      • Johns Hopkins University
  • Massachusetts
    • Boston, Massachusetts, United States, 02114
      • Massachusetts General Brigham
  • Michigan
    • Detroit, Michigan, United States, 48202
      • Wayne State University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Pediatric and adult patients presenting to the Emergency Department or Urgent Care Center with signs and symptoms suggestive of acute bacterial or viral infection.

The study sample size will be divided into the following:

• Pediatric (>90 days - <18 yrs. of age) population sample target of 30 enrolled subjects.
• Adult (≥18 yrs. of age) population sample target of 214 adult patients enrolled subjects.

The target population will be representative of US demographics. This sample size aligns with comparator device studies. Pediatric sample collection will be separated into the following three (3) age categories:

• Age over 90 days to <2 yrs.
• Age 2 yrs. to <12 yrs.
• Age 12 yrs. to <18 yrs.

Description

Inclusion Criteria:

• Over 90 days of age.
• Clinical suspicion of acute bacterial or viral infection.
• Temperature ≥ 37.8°C (100°F) (any body site, any measurement device, including self-reported) or tactile fever, either of them noted at least once within the last 7 days.
• Current disease duration ≤ 7 days.

Exclusion Criteria:

• Previously enrolled

• Insufficient sample volumes obtained

  • For the adult and pediatric populations, < 1.2 mL serum volume
• Sample handling errors
• Another unrelated episode of febrile infection within the past 2 weeks
• Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
• ≥48 hours of oral antibiotic treatment
• ≥12 hours of intravenous\intramuscular antibiotic treatment
• Human Immunodeficiency Viruses (HIV), Hepatitis B Virus (HBV), or Hepatitis C Virus (HCV) infection (self-declared or known from medical records)
• A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen
• Active inflammatory disease (e.g., Inflammatory Bowel Disease [IBD], Systemic Lupus Erythematosus [SLE], Juvenile Idiopathic Arthritis [JIA], Rheumatoid Arthritis [RA], Kawasaki, other vasculitis)
• Major trauma and\or burns in the last 7 days.
• Major surgery in the last 7 days
• Congenital immune deficiency (CID)

• Acquired immune deficiency\modulation state including

  1. Active malignancy treated within last 6 months
  2. Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

  i. 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 ii. Monoclonal antibodies, anti-TNF agents iii. Intravenous immunoglobulin (IVIG) iv. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate v. G/GM-CSF Interferons c. Post solid organ/bone marrow transplant patients d. Asplenia, sickle cell disease

• Indwelling central venous catheter
• Cystic Fibrosis
• Pregnancy - self-reported or medically known

• Other severe illnesses that affect life expectancy and quality of life such as:

  1. Severe psychomotor retardation
  2. Congenital metabolic disorder
  3. End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Adult and Pediatrics; A minimum of 244 serum samples will be collected at a minimum of two (2) US locations from enrolled pediatric and adult patients presenting signs and symptoms suggestive of acute bacterial or viral infection. The number of patients enrolled is based on total volume required to run analytical comparison studies under a future testing protocol.

Other: Adult and Pediatrics; This is an observational study. This protocol is for blood draw enrollment. These samples will be collected and binned by their results from the MeMed BV assay. Samples collected will be used for an analytical comparison study under a future testing protocol. These samples will be used to establish the diagnostic performance of MeMed BV test on BEC Access Immunoassay Systems for differentiating bacterial from viral infection.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood Specimen Collection	Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection	Less or equal to seven days

Collaborators and Investigators

• Sponsor: Beckman Coulter, Inc.
• Collaborators: MeMed Diagnostics Ltd.
• Investigators: Study Director: David Haan, Beckman Coulter, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2024
• Primary Completion (Actual): January 31, 2025
• Study Completion (Actual): April 30, 2025

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: April 18, 2024
• First Posted (Actual): April 23, 2024

Study Record Updates

• Last Update Posted (Estimated): June 5, 2025
• Last Update Submitted That Met QC Criteria: June 3, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Virus Diseases; Bacterial Infections
• Other Study ID Numbers: MM-01-24; MMP-01-24 (Other Identifier: Beckman Coulter, Inc.)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No