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

Acute Infection Clinical Trial

— Apollo  

Official title:

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)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04690569
• Other study ID #: MMD010
• Status: Completed
• Start date: May 3, 2019
• Est. completion date: November 22, 2020

Study information

• Verified date: December 2020
• Source: MeMed Diagnostics Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1384
• Est. completion date: November 22, 2020
• Est. primary completion date: November 22, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 90 Days and older

Eligibility

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)

Related Conditions & MeSH terms

• Acute Infection
• Communicable Diseases
• Infection
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
Israel	Hillel Yaffe Medical Center	Hadera
Israel	Carmel Medical Center	Haifa
United States	Johns Hopkins	Baltimore	Maryland
United States	Boston Children's Hospital	Boston	Massachusetts
United States	American Family Care Urgent Care	Chattanooga	Tennessee
United States	American Family Care Urgent Care	Easley	South Carolina
United States	Texas Children's Hospital	Houston	Texas
United States	University of Texas Health Science Center	Houston	Texas
United States	Maimonides Medical Center	New York	New York
United States	University of Pittsburgh Medical Center	Pittsburgh	Pennsylvania
United States	American Family Care Urgent Care	Powdersville	South Carolina

Sponsors (1)

Lead Sponsor	Collaborator
MeMed Diagnostics Ltd.

Countries where clinical trial is conducted

United States,  Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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