Collecting blood samples to differentiate between bacterial and viral infections

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

This study is testing a new blood test to see if it can help doctors tell the difference between bacterial and viral infections in both kids and adults.

Quick facts

• Study type: Observational
• Enrollment: 400 (estimated)
• Ages: 90 Days to 89 Years
• Sex: All
• Sponsor: Beckman Coulter, Inc. (Industry-sponsored)
• Drugs / interventions: Methotrexate, Cyclophosphamide, prednisone
• Locations: 4 sites (Indianapolis, Indiana and 3 other locations)
• Trial ID: NCT06379061 on ClinicalTrials.gov

What this trial studies

This observational study aims to gather blood specimens and clinical data from pediatric and adult patients who show signs of acute bacterial or viral infections. Participants will be recruited from hospitals, emergency departments, and urgent care centers. The collected samples will be analyzed using the MeMed BV™ assay to evaluate its effectiveness in distinguishing between bacterial and viral infections. The study will involve method comparison and concordance testing using advanced immunoassay analyzers.

Who should consider this trial

Good fit: Ideal candidates include individuals over 90 days old with clinical signs of acute bacterial or viral infection and a fever.

Not a fit: Patients with unrelated febrile infections, those currently on antibiotics, or with specific viral infections like HIV or hepatitis will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to more accurate and timely diagnoses of bacterial versus viral infections, improving patient management.

How similar studies have performed: Other studies have shown promise in using similar diagnostic approaches, indicating potential for success in this study.

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)

Where this trial is running

Indianapolis, Indiana and 3 other locations

• Indiana University School of Medicine — Indianapolis, Indiana, United States (Recruiting)
• Johns Hopkins University — Baltimore, Maryland, United States (Recruiting)
• Massachusetts General Brigham — Boston, Massachusetts, United States (Recruiting)
• Wayne State University — Detroit, Michigan, United States (Recruiting)

Study contacts

• Study coordinator: Wendy Nelson, PhD

Conditions Infection, Bacterial; Infection Viral