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

Completed

Conditions studied: Infection, Bacterial, Infection Viral

In brief

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.

Key facts

Study ID

NCT06379061

Run by

Beckman Coulter, Inc.

People needed

650

Starts

2024-06-12

Expected to finish

2025-04-30

Last updated by the study team

2025-06-05

Who can join

Age: 0 and older, up to 89. Sex: any. Healthy volunteers: not accepted.

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
• Active malignancy treated within last 6 months
• 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:
• Severe psychomotor retardation
• Congenital metabolic disorder
• End stage renal disease, advanced heart failure (NYHA 3/4), advanced COPD (GOLD 3/4)

Where it is running

• 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

Full record on ClinicalTrials.gov

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