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

Acute Infection Clinical Trial

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)

Status Completed

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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Acute Infection
• Communicable Diseases
• Infection
• Virus Diseases

• NCT number: NCT04690569
• Study type: Observational
• Source: MeMed Diagnostics Ltd.
• Status: Completed
• Start date: May 3, 2019
• Completion date: November 22, 2020