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

NCT05897801 | Completed

• 1 other identifier: CRONUS
• Study Type: observational
• Target: 230
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Viral Infection; Bacterial Infections; Multi-antibiotic Resistance; Respiratory Tract Infections

Keywords

Infections; Gut colonization; Respiratory track infections

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• 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

  Through study completion, an average of 1 year

Study Arms (1)

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®

Interventions

MeMed BV® DIAGNOSTIC_TEST

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.

Patients with a respiratory tract infection

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hellenic Institute for the Study of Sepsis: lead

Study Sites (3)

Emergency Department of ATTIKON University General Hospital

Attiki, Chaidari, 12462, Greece

Location

Emergency Department of Tzaneion General Hospital

Attiki, Piraeus, 18536, Greece

Location

General Hospital of Elefsina 1st Department of Internal Medicine

Elefsina, 19600, Greece

Location

MeSH Terms

Conditions

Virus Diseases; Bacterial Infections; Respiratory Tract Infections; Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Respiratory Tract Diseases

Study Officials

• Evangelos Giamarellos-Bourboulis, MD,PhD

  Hellenic Institute for the Study of Sepsis

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 22, 2023
• First Posted: June 9, 2023
• Study Start: May 29, 2023
• Primary Completion: December 18, 2023
• Study Completion: January 31, 2024
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share

Locations

GR (3)