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

NCT06379061 | Completed FDA Device

• 2 other identifiers: MM-01-24MMP-01-24
• Study Type: observational
• Target: 650
• Locations: 1 country
• Sites: 4

Brief Summary

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.

Conditions

Infection, Bacterial; Infection Viral

Outcome Measures

Primary Outcomes (1)

• Blood Specimen Collection

  Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection

  Less or equal to seven days

Study Arms (1)

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

Interventions

Adult and Pediatrics OTHER

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.

Adult and Pediatrics

Eligibility Criteria

• Age: 90 Days - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Beckman Coulter, Inc.: lead
• MeMed Diagnostics Ltd.: collaborator

Study Sites (4)

Indiana University School of Medicine

Indianapolis, Indiana, 46202, United States

Location

Johns Hopkins University

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Brigham

Boston, Massachusetts, 02114, United States

Location

Wayne State University

Detroit, Michigan, 48202, United States

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Serum and Plasma Specimens fully de-identified

MeSH Terms

Conditions

Bacterial Infections; Virus Diseases

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Officials

• David Haan

  Beckman Coulter, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 18, 2024
• First Posted: April 23, 2024
• Study Start: June 12, 2024
• Primary Completion: January 31, 2025
• Study Completion: April 30, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (4)