Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
T
Thomas E. Davis
Primary Investigator
Enrolling By Invitation
90 days - 89 years
All
Phase
N/A
1 participants needed
2 Locations
Brief description of study
What is the purpose of this study?
The purpose of this study is to collect blood specimens and clinical data from adult patients (≥18 yrs.) presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to check how well MeMed BV™, a lab test, can tell the difference between bacterial and viral infections. We will compare the results using the Beckman Coulter Access 2 and DxI 9000 Immunoassay Analyzers to see how effective it is in diagnosing infections. This study will eventually help physicians to treat sick patients better and faster.
The purpose of this study is to collect blood specimens and clinical data from adult patients (≥18 yrs.) presenting with signs and symptoms suggestive of acute bacterial or viral infection. These samples will be used to check how well MeMed BV™, a lab test, can tell the difference between bacterial and viral infections. We will compare the results using the Beckman Coulter Access 2 and DxI 9000 Immunoassay Analyzers to see how effective it is in diagnosing infections. This study will eventually help physicians to treat sick patients better and faster.
THIS STUDY IS ENROLLING BY INVITATION ONLY - Potential participants with signs and symptoms suggestive of acute bacterial or viral infection will be approached as they present to the emergency department by their doctor and research team about study participation. The consent process and research procedures will occur during the subjects regularly scheduled clinic visit in a private room..
Detailed description of study
What will happen during the study?
- We will draw up to 3.5 milliliters (less than 1 teaspoon) of blood from a vein in participant's arm to be collected for future analytical testing.
- The MeMed Bacterial/Viral (BV) test combines results from three (3) proteins in the blood in response to an infection into a score between 0 and 100 that can be used with clinical evaluation and other laboratory findings to differentiate bacterial from viral infection.
- There are no other visits or activities required for this study.
Eligibility of study
You may be eligible for this study if you meet the following criteria:
- Conditions: Viral Infection, Acute Bacterial Infection
-
Age: 90 days - 89 years
-
Gender: All
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
- 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)
Updated on
14 Apr 2025.
Study ID: PATH-BECKMAN-MM-01-24, 23089
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