Clinical trial NCT05439551: Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform (Perseverance Study)
Official title: A Prospective Multi-center Sample Collection Study for Evaluating the Analytical Equivalency of Serum and Whole Blood Samples Run on the MeMed Key® Platform ("Perseverance" Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Acute Infection
Lead sponsor: MeMed Diagnostics Ltd.
Sponsor class: INDUSTRY
First posted: 2022-06-30
Enrollment: 215
Sex: ALL
Minimum age (years): 90
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: ED, Hospital admitted, and urgent care center patients over the age of 90 days, with clinical suspicion of acute bacterial or viral infection.

Brief summary: This is a Prospective, multi-center, sample collection study enrolling pediatric and adult subjects presented to the ED/Urgent care, with symptoms consistent with acute bacterial or viral infection will be recruited according to eligibility criteria. The study is designed to measure the MeMed BV®️ score in whole blood and serum samples and demonstrate the equivalence between the two matrices. Patients will be managed according to the current standard of care per standard institutional procedures.


Eligibility criteria: Inclusion Criteria:

1. Written informed consent must be obtained from the patient or his/her legal guardian. For children under 18 years old, written informed consent from the legal guardian must be obtained and assent from the patient may be required depending on the local requirements.
2. Over 90 days of age.
3. Clinical suspicion of acute bacterial or viral infection.
4. Symptoms of acute infectious disease \< 7 days.
5. Experienced fever at least once within the last 7 days (self-reported or Temperature ≥ 37.8°C (100°F)).

Exclusion Criteria:

1. HIV, HBV, active HCV, or active Tuberculosis infection (self-declared or known from medical records).
2. Suspicion and/or confirmed diagnosis of infectious gastroenteritis/ colitis.
3. Active inflammatory disease (e.g., IBD, SLE, JIA, RA, Kawasaki, other vasculitis).
4. Pregnancy- self reported or medically confirmed.
5. Active malignancy.
6. Congenital or acquired immune deficiency (CID).
7. A proven or suspected infection on presentation with Mycobacterial (e.g., Tuberculosis, MAC), parasitic or fungal (e.g., Candida, Histoplasma, Aspergillus) pathogen.
8. Significant trauma or burns in the last 7 days.
9. Patients that have undergone major surgery in the last 7 days.
10. Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

    1. 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
    2. Monoclonal antibodies, anti-TNF agents
    3. Intravenous immunoglobulin (IVIG)
    4. Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate
    5. G/GM-CSF, Interferons.

Primary outcomes:
measure: Measuring the MeMed BV® score with whole blood and serum samples from patients suspected of acute bacterial or viral infection and demonstrating the equivalence between the two matrices.
timeFrame: Through study completion, an average of 18 months
Secondary outcomes:
Other outcomes:
Locations:
city: Brooklyn
country: United States
facility: Maimonides Medical Center
state: New York
city: Easley
country: United States
facility: Urgent Care Clinical Trials @ AFC Urgent Care- Easley
state: South Carolina
city: Hadera
country: Israel
facility: Hillel Yaffe Medical Center
city: Haifa
country: Israel
facility: Carmel Medical Center
city: Tel Aviv
country: Israel
facility: Sourasky Medical Center - Ichilov
Study officials:
References: