NCT04690569: Apollo

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

Completed Last updated 5 January 2021

What this trial tests

trial testing MeMed BV in Acute Infection in 1,384 participants. Completed in 22 November 2020.

Timeline

3 May 2019

Primary endpoint
22 November 2020

22 November 2020

Quick facts

Lead sponsor	MeMed Diagnostics Ltd.
Status	Completed
Study type	OBSERVATIONAL
Enrollment	1,384
Start date	3 May 2019
Primary completion	22 November 2020
Estimated completion	22 November 2020
Sites	11 locations across United States, Israel

Drugs / interventions tested

• MeMed BV

Conditions studied

• Acute Infection — all drugs for Acute Infection →

Sponsor

MeMed Diagnostics Ltd.

Who can join

90 Days and older, any sex, with Acute Infection. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

6 peer-reviewed publications reference this trial (live from Europe PMC):

1. A point-of-need platform for rapid measurement of a host-protein score that differentiates bacterial from viral infection: Analytical evaluation.
   Hainrichson M, Avni N, Eden E, Feigin P, et al · · 2023 · cited 24× · PMID 35487256 · DOI 10.1016/j.clinbiochem.2022.04.012
2. A rapid host-protein test for differentiating bacterial from viral infection: Apollo diagnostic accuracy study.
   Bachur RG, Kaplan SL, Arias CA, Ballard N, et al · · 2024 · cited 21× · PMID 38721037 · DOI 10.1002/emp2.13167
3. Development of a Reference Standard to Assign Bacterial Versus Viral Infection Etiology Using an All-inclusive Methodology for Comparison of Novel Diagnostic Tool Performance.
   Allen C, Deanehan JK, Dotan Y, Eisenberg MA, et al · · 2025 · cited 7× · PMID 39750735 · DOI 10.1093/cid/ciae656
4. P-831. Association Between Adherence of Antibiotic Practice with a Bacterial/Viral Test Result and Outcomes in US ED/UC
   · 2026
5. A Host-Protein Test for Differentiating Bacterial From Viral Infection: Diagnostic Accuracy in Elderly Patients.
   Gottlieb TM, Orr Y, Hamami H, Navon R, et al · · 2025 · PMID 41114128 · DOI 10.1016/j.acepjo.2025.100245
6. O02 TRAIL, IP-10, CRP host-protein signature score distinguishes between viral and bacterial infection in sepsis patients
   Stas J, Arias C, Bachur R, Esposito S, et al · · 2022