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

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Key information

Conditions

Acute Infection

Age range

90 day and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Hillel Yaffe Medical Center, Hadera, Israel

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.

Time frame: Through study completion, an average of 18 months

Establish the diagnostic performance of the MeMed BV™ Test for differentiating bacterial from viral infection using expert adjudication comparator method.

Sponsors and collaborators

Lead sponsor

MeMed Diagnostics Ltd.

Industry

Registry information

Official study 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)

Acronym: Apollo

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2020
First posted: Dec 30, 2020
Registry last updated: Jan 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed