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

Completed

Conditions studied: Acute Infection

In brief

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.

Key facts

Study ID

NCT04690569

Run by

MeMed Diagnostics Ltd.

People needed

1384

Starts

2019-05-03

Expected to finish

2020-11-22

Last updated by the study team

2021-01-05

Who can join

Age: 0 and older. Sex: any. Healthy volunteers: accepted.

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
• 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

Where it is running

• Johns Hopkins — Baltimore, Maryland, United States
• Boston Children's Hospital — Boston, Massachusetts, 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 — Easley, South Carolina, United States
• American Family Care Urgent Care — Powdersville, South Carolina, United States
• American Family Care Urgent Care — Chattanooga, Tennessee, United States
• Texas Children's Hospital — Houston, Texas, United States
• University of Texas Health Science Center — Houston, Texas, United States
• Hillel Yaffe Medical Center — Hadera, Israel
• Carmel Medical Center — Haifa, Israel

Full record on ClinicalTrials.gov

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