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

Description

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

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Study Overview

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Study Details

Study overview

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.

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

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

Condition
Infection, Bacterial
Intervention / Treatment

-

Contacts and Locations

Indianapolis

Indiana University School of Medicine, Indianapolis, Indiana, United States, 46202

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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.
  • * 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:
  • * 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)

Ages Eligible for Study

90 Days to 89 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Beckman Coulter, Inc.,

David Haan, STUDY_DIRECTOR, Beckman Coulter, Inc.

Study Record Dates

2025-03-31