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

Infection, Bacterial Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06379061
• Other study ID #: MM-01-24
• Status: Recruiting
• Start date: June 12, 2024
• Est. completion date: March 31, 2025

Study information

• Verified date: June 2024
• Source: Beckman Coulter, Inc.
• Contact: Wendy Nelson, PhD
• Phone: 6513370598
• Email: wdnelson[@]beckman.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: March 31, 2025
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 90 Days to 89 Years

Eligibility

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)

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infection Viral
• Infection, Bacterial
• Infections
• Virus Diseases

Intervention

Other:
• 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.

Locations

Country	Name	City	State
United States	Indiana University School of Medicine	Indianapolis	Indiana

Sponsors (2)

Lead Sponsor	Collaborator
Beckman Coulter, Inc.	MeMed Diagnostics Ltd.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Blood Specimen Collection	Collect blood specimens across multiple age ranges presenting symptoms of acute or viral infection	Less or equal to seven days