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

NCT ID: NCT06379061

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 650 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2025-04-30

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.

Conditions

Infection, Bacterial; Infection Viral

Study Design

• Observational Model Type: CASE_ONLY
• Study Time Perspective: PROSPECTIVE

Study Groups

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.

Adult and Pediatrics

Intervention Type: 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.

Interventions

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.

Intervention Type: OTHER

Eligibility Criteria

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)

• Minimum Eligible Age: 90 Days
• Maximum Eligible Age: 89 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MeMed Diagnostics Ltd.

INDUSTRY

Sponsor Role: collaborator

Beckman Coulter, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

David Haan

Role: STUDY_DIRECTOR

Beckman Coulter, Inc.

Locations

Indiana University School of Medicine

Indianapolis, Indiana, United States

Johns Hopkins University

Baltimore, Maryland, United States

Massachusetts General Brigham

Boston, Massachusetts, United States

Wayne State University

Detroit, Michigan, United States

Countries

United States

Other Identifiers

MMP-01-24

Identifier Type: OTHER

Identifier Source: secondary_id

MM-01-24

Identifier Type: -

Identifier Source: org_study_id