Establish MeMed BV™ Performance for Differentiating Bacterial From Viral Infection in Suspected Acute Infection Patients (APOLLO STUDY) (Apollo)

Prospective, Multi-Center, Observational, Blinded Study to Establish the Diagnostic Performance of the MeMed BV™ Test for Differentiating Bacterial From Viral Infection in Patients With Suspected Acute Bacterial or Viral Infection ("APOLLO" STUDY)

Prospective, multi-center, observational, blinded study, enrolling pediatric and adult subjects. Eligible ED\Urgent care and hospital admitted patients with symptoms consistent with acute bacterial or viral infection and healthy subjects will be recruited according to the eligibility criteria. Each participant will undergo a thorough investigation upon recruitment that includes documenting clinical, radiological, laboratory and microbiological information for determining their health status.

Follow-up data will be collected via a phone call. Diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection will be assessed using an expert adjudication comparator method.

The study will be run in a blinded fashion: site personnel will be blinded to the comparator method outcomes, and the expert panel will be blinded to the results of the index test. Results of the index test will not be revealed to the attending clinician and so will not influence patient management.

Study Overview

• Status: Completed
• Conditions: Acute Infection
• Intervention / Treatment: Diagnostic test: MeMed BV

• Study Type: Observational
• Enrollment (Actual): 1384

Contacts and Locations

Study Locations

• Israel
  • Hadera, Israel, 38100
    • Hillel Yaffe Medical Center
  • Haifa, Israel, 3436212
    • Carmel Medical Center
• United States
  • Maryland
    • Baltimore, Maryland, United States, 21218
      • Johns Hopkins
  • Massachusetts
    • Boston, Massachusetts, United States, 02115
      • Boston Children's Hospital
  • New York
    • New York, New York, United States, 11219
      • Maimonides Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15260
      • University of Pittsburgh Medical Center
  • South Carolina
    • Easley, South Carolina, United States, 29640
      • American Family Care Urgent Care
    • Powdersville, South Carolina, United States, 29611
      • American Family Care Urgent Care
  • Tennessee
    • Chattanooga, Tennessee, United States, 37421
      • American Family Care Urgent Care
  • Texas
    • Houston, Texas, United States, 77030
      • Texas Children's Hospital
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 months and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Hospital admitted, ED and urgent care center patients over the age of 90 days, with suspected acute bacterial or viral infection and healthy subjects.

Description

Inclusion Criteria:

• 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 and assent from the patient (depending on the local requirements)
• 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:

• 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
• HIV, HBV, or 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. IBD, SLE, JIA, 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

  • Current treatment with immune-suppressive or immune-modulating therapies, including without limitations:

    • 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
    • Monoclonal antibodies, anti-TNF agents
    • Intravenous immunoglobulin (IVIG)
    • Cyclosporine, Cyclophosphamide, Tacrolimus, Azathioprine, Methotrexate
    • G/GM-CSF, Interferons
  • Post solid organ/bone marrow transplant patients
  • 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)

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Infectious; Eligible pediatric and adult patients from ED\Urgent care and hospital admitted, with symptoms consistent with acute bacterial or viral infection.	Diagnostic test: MeMed BV; The MeMed BV™ Test is an immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The test is indicated for use in patients presenting to the ED, urgent care center and inpatients with suspected acute bacterial or viral infection. The MeMed BV™ Test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV™ test is intended for in vitro diagnostic use only.
Healthy; For the purpose of establishing a normal reference range.	Diagnostic test: MeMed BV; The MeMed BV™ Test is an immunoassay that measures three non-microbial (host) proteins (TRAIL, IP-10, and CRP) in adult and pediatric serum samples. The test is intended for use in conjunction with clinical assessments and other laboratory findings as an aid to differentiate bacterial from viral infection. The test is indicated for use in patients presenting to the ED, urgent care center and inpatients with suspected acute bacterial or viral infection. The MeMed BV™ Test generates a numeric score that falls within discrete interpretation bins based on the increasing likelihood of bacterial infection. The MeMed BV™ test is intended for in vitro diagnostic use only.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.	Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.	Through study completion, an average of 18 months

Collaborators and Investigators

• Sponsor: MeMed Diagnostics Ltd.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2019
• Primary Completion (Actual): November 22, 2020
• Study Completion (Actual): November 22, 2020

Study Registration Dates

• First Submitted: December 24, 2020
• First Submitted That Met QC Criteria: December 29, 2020
• First Posted (Actual): December 30, 2020

Study Record Updates

• Last Update Posted (Actual): January 5, 2021
• Last Update Submitted That Met QC Criteria: December 30, 2020
• Last Verified: December 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Infections; Communicable Diseases; Virus Diseases
• Other Study ID Numbers: MMD010

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes