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

Bacterial Infections Clinical Trial

— CRONUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05897801
• Other study ID #: CRONUS
• Status: Completed
• Start date: May 29, 2023
• Est. completion date: January 31, 2024

Study information

• Verified date: March 2024
• Source: Hellenic Institute for the Study of Sepsis
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 230
• Est. completion date: January 31, 2024
• Est. primary completion date: December 18, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Bacterial Infections
• Communicable Diseases
• Infections
• Multi-antibiotic Resistance
• Respiratory Tract Infections
• Viral Infection
• Virus Diseases

Intervention

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.

Locations

Country	Name	City	State
Greece	Emergency Department of ATTIKON University General Hospital	Attiki	Chaidari
Greece	Emergency Department of Tzaneion General Hospital	Attiki	Piraeus
Greece	General Hospital of Elefsina 1st Department of Internal Medicine	Elefsína

Sponsors (1)

Lead Sponsor	Collaborator
Hellenic Institute for the Study of Sepsis

Country where clinical trial is conducted

Greece, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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