Clinical trial NCT06379061: Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
Official title: Access MeMed BV Assay Clinical Study Collection Protocol - Infectious Adult and Pediatric Cohorts
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Infection, Bacterial
Infection Viral
Lead sponsor: Beckman Coulter, Inc.
Sponsor class: INDUSTRY
Collaborators: name: MeMed Diagnostics Ltd.
First posted: 2024-04-23
Enrollment: 650
Sex: ALL
Minimum age (years): 90
Maximum age (years): 89
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pediatric and adult patients presenting to the Emergency Department or Urgent Care Center with signs and symptoms suggestive of acute bacterial or viral infection.

The study sample size will be divided into the following:

* Pediatric (\>90 days - \<18 yrs. of age) population sample target of 30 enrolled subjects.
* Adult (≥18 yrs. of age) population sample target of 214 adult patients enrolled subjects.

The target population will be representative of US demographics. This sample size aligns with comparator device studies. Pediatric sample collection will be separated into the following three (3) age categories:

* Age over 90 days to \<2 yrs.
* Age 2 yrs. to \<12 yrs.
* Age 12 yrs. to \<18 yrs.

Brief 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.

Detailed 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.

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)

Primary outcomes:
measure: Blood Specimen Collection
timeFrame: Less or equal to seven days
Secondary outcomes:
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Indiana University School of Medicine
state: Indiana
city: Baltimore
country: United States
facility: Johns Hopkins University
state: Maryland
city: Boston
country: United States
facility: Massachusetts General Brigham
state: Massachusetts
city: Detroit
country: United States
facility: Wayne State University
state: Michigan
Study officials:
affiliation: Beckman Coulter, Inc.
name: David Haan
role: STUDY_DIRECTOR
References: