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

NCT04690569 | Completed FDA Device

• 1 other identifier: MMD010
• Study Type: observational
• Target: 1,384
• Locations: 2 countries
• Sites: 11

Brief Summary

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.

Conditions

Acute Infection

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

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

Healthy

For the purpose of establishing a normal reference range.

Diagnostic Test: MeMed BV

Interventions

MeMed BV DIAGNOSTIC_TEST

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; Infectious

Eligibility Criteria

• Age: 90 Days+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• MeMed Diagnostics Ltd.: lead

Study Sites (11)

Johns Hopkins

Baltimore, Maryland, 21218, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

Maimonides Medical Center

New York, New York, 11219, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15260, United States

Location

American Family Care Urgent Care

Easley, South Carolina, 29640, United States

Location

American Family Care Urgent Care

Powdersville, South Carolina, 29611, United States

Location

American Family Care Urgent Care

Chattanooga, Tennessee, 37421, United States

Location

Texas Children's Hospital

Houston, Texas, 77030, United States

Location

University of Texas Health Science Center

Houston, Texas, 77030, United States

Location

Hillel Yaffe Medical Center

Hadera, 38100, Israel

Location

Carmel Medical Center

Haifa, 3436212, Israel

Location

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2020
• First Posted: December 30, 2020
• Study Start: May 3, 2019
• Primary Completion: November 22, 2020
• Study Completion: November 22, 2020
• Last Updated: January 5, 2021

Record last verified: 2020-12

Locations

IL (2); US (9)