NCT04690569

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

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)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 1,384 (actual)
• Sponsor: MeMed Diagnostics Ltd. · Industry
• Sex: All
• Age: 90 Days
• Healthy volunteers: Accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2019-05-03
• Primary completion: 2020-11-22
• Completion: 2020-11-22
• First posted: 2020-12-30
• Last updated: 2021-01-05

Locations

11 sites across 2 countries: United States, Israel

Regulatory

• FDA-regulated device study