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

Recruiting

• Conditions: Infection Viral; Infection, Bacterial
• Interventions: Other: Adult and Pediatrics

• Registration Number: NCT06379061
• Lead Sponsor: Beckman Coulter, Inc.

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.

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 Timeline

• Study First Submitted: 2024-04-18
• Study First Submitted QC: 2024-04-18
• Study First Posted: 2024-04-23
• Study Start: 2024-06-12
• Status Verified: 2024-12
• Primary Completion: 2025-01-31
• Last Update Submitted: 2025-03-05
• Last Update Posted: 2025-03-07
• Study Completion: 2025-03-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Adult and Pediatrics	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.

Primary Outcome Measures

Name	Time	Method
Blood Specimen Collection	Less or equal to seven days	Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection

Trial Locations

Locations (4)

Johns Hopkins University; 🇺🇸 Baltimore, Maryland, United States

Massachusetts General Brigham; 🇺🇸 Boston, Massachusetts, United States

Wayne State University; 🇺🇸 Detroit, Michigan, United States

Indiana University School of Medicine; 🇺🇸 Indianapolis, Indiana, United States