Distinguishing Bacterial and Viral Infections by MeMed BV® Test to Limit Gut Colonization by MDRO (CRONUS)

A CLINICAL STUDY OF THE MeMed BV® TEST TO DISTINGUISH BETWEEN BACTERIAL AND VIRAL INFECTIONS AND LIMIT GUT COLONIZATION BY MULTIDRUG RESISTANT MICROORGANISMS

The fast increase of Multidrug-resistant microorganisms (MDRO) due to the high amount of antimicrobials being poorly used may be limited by better regulating antimicrobial usage globally. The goal of this observational study is the performance of the MeMed BV® test in the MeMed Key® device at the emergency department to a) support the differential diagnosis between bacterial and viral infections of the respiratory tract and b) provide evidence of how the use of this test may limit gut colonization by MDRO.

Study Overview

• Status: Completed
• Conditions: Respiratory Tract Infections; Bacterial Infections; Viral Infection; Multi-antibiotic Resistance
• Intervention / Treatment: Diagnostic test: MeMed BV®

Detailed Description

Antimicrobial resistance is one of the major threats to the society. One major driver of this phenomenon is the extensive use of antibiotics particularly during the winter months as empirical use for respiratory tract infections. Most of these infections, namely acute exacerbation of chronic obstructive pulmonary disease (AECOPD) and acute bronchitis, are of viral origin and no antibiotics need to be prescribed. To limit the ambiguity of prescribing physicians leading them to unnecessary prescription of antibiotics, one new point-of-care test has been developed which may assist to distinguish between bacterial and viral infections.

This test is called MeMed BV® and is providing the integrative information of three measurable parameters in blood, namely TRAIL (tumour necrosis factor-related apoptosis-inducing ligand), IP-10 (interferon-gamma-induced protein-10) and CRP (C-reactive protein). TRAIL and CRP are increased in the case of bacterial infection; IP-10 is increased in viral infections; and the integrative algorithm suggests the likelihood for a patient to present with bacterial infection, with viral infection or to be at an intermediate state. Based on the results of the Appolo clinical study, the use of the MeMed BV® test which runs in the MeMed Key® device have been registered by the European Medicines Agency and by the Food and Drug Administration (FDA) of the United States for use in the Emergency department (ED) of differentiate between bacterial and viral infections.

The present study is aiming to the performance of the MeMed BV® test in the MeMed Key® device at the ED to a) support the differential diagnosis between bacterial and viral infections of the respiratory tract and b) provide evidence of how the use of this test may limit gut colonization by MDRO.

• Study Type: Observational
• Enrollment (Actual): 230

Contacts and Locations

Study Locations

• Greece
  • Elefsína, Greece, 19600
    • General Hospital of Elefsina 1st Department of Internal Medicine
  • Chaidari
    • Attiki, Chaidari, Greece, 12462
      • Emergency Department of ATTIKON University General Hospital
  • Piraeus
    • Attiki, Piraeus, Greece, 18536
      • Emergency Department of Tzaneion General Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

Screening will be done for the inclusion and exclusion criteria in all patients admitted in the participating sites. Participants will be patients meeting all inclusion criteria and none of the exclusion criteria.

Description

Inclusion Criteria:

• Age 18 years or more
• Both genders
• Written informed consent provided by participants or their legal representatives
• Symptoms compatible with the diagnosis of respiratory tract infection defined as at least one of: fever (core temperature more than or equal to 37.50C), chills, sore throat, myalgias, sudden onset of headache, running nose
• Onset of symptoms the last 7 days

Exclusion Criteria:

• Fever (core temperature more than or equal to 37.50C) for more than 7 days
• Neutropenia defined as less than 1,000 neutrophils/mm3
• Intake of chemotherapy for any malignancy
• Intake of radiotherapy for any malignancy
• Medical history of known active infection by the human immunodeficiency virus (HIV) or hepatitis B virus (HBV) or hepatitis C virus (HCV)
• Pregnancy or lactation
• Any acute trauma
• Any operation the last 7 days
• Presence of acute burns

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with a respiratory tract infection; Patients entering the emergency department of the sites, presenting with symptoms compatible with the diagnosis of respiratory tract infection.	Diagnostic test: MeMed BV®; One blood sampling of 3ml will be drawn on the first day for the performance of the MeMed BV® test. Two rectal swabs will be taken for determining the MDRO gut colonization. Patient information regarding the specific respiratory tract infection and the treatment regimen being prescribed will be recorded in the eCRF made specifically for this trial.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The change of the physicians decisions for the prescribed treatment based on the MeMed BV® test	The change of the physicians decisions for the prescribed treatment based on the MeMed BV® test	Through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The accurate prediction of the viral or the bacterial infection a patient is suffering from using the MeMed BV® test	The accurate prediction of the viral or the bacterial infection a patient is suffering from using the MeMed BV® test	Through study completion, an average of 1 year
Exploratory endpoint	The rate of gut colonization by MDRO between patients for whom physician decision to receive antibiotics was impacted by the results of the MeMed BV® test and patients for whom physician decision to receive antibiotics was not impacted by the results of the MeMed BV®.	Through study completion, an average of 1 year

Collaborators and Investigators

• Sponsor: Hellenic Institute for the Study of Sepsis
• Investigators: Study Chair: Evangelos Giamarellos-Bourboulis, MD,PhD, Hellenic Institute for the Study of Sepsis

Study record dates

Study Major Dates

• Study Start (Actual): May 29, 2023
• Primary Completion (Actual): December 18, 2023
• Study Completion (Actual): January 31, 2024

Study Registration Dates

• First Submitted: May 22, 2023
• First Submitted That Met QC Criteria: June 1, 2023
• First Posted (Actual): June 9, 2023

Study Record Updates

• Last Update Posted (Estimated): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: Infections; Gut colonization; Respiratory track infections
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Disease Attributes; Bacterial Infections and Mycoses; Infections; Communicable Diseases; Virus Diseases; Respiratory Tract Infections; Bacterial Infections
• Other Study ID Numbers: CRONUS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No