Viral InfectionCRONUSNCT05897801
Distinguishing Bacterial and Viral Infections by MeMed BV® Test to Limit Gut Colonization by MDRO
An observational study of Viral Infection and Bacterial Infections, run by Hellenic Institute for the Study of Sepsis at 3 sites in Greece.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Viral Infection, Bacterial Infections, Multi-antibiotic Resistance
- What is being tested?
- MeMed BV®
- How many people
- 230 participants
- Where
- 3 sitesGreece
- Study dates
- 29 May 2023to 31 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- Any acute trauma
- Any operation the last 7 days
- Presence of acute burns
Trial locations and contacts
3 sites in 1 country.
Greece3 sites
Emergency Department of ATTIKON University General Hospital
Attiki, Chaidari, 12462
Emergency Department of Tzaneion General Hospital
Attiki, Piraeus, 18536
General Hospital of Elefsina 1st Department of Internal Medicine
Elefsina, 19600
About this study
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
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.
Read the 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.
- Conditions
- Viral Infection, Bacterial Infections, Multi-antibiotic Resistance, Respiratory Tract Infections
- Being tested
- MeMed BV®
- Keywords
- Infections, Gut colonization, Respiratory track infections
- Medical subject headings
- Virus Diseases, Bacterial Infections, Respiratory Tract Infections, Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: MeMed BV® |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
The accurate prediction of the viral or the bacterial infection a patient is suffering from using the MeMed BV® test
Measured: 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®.
Measured: Through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2023
- Study start29 May 2023
- Primary completion18 Dec 2023
- Study completion31 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Viral InfectionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 230 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hellenic Institute for the Study of Sepsis
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Evangelos Giamarellos-Bourboulis, MD,PhD, Study chair, Hellenic Institute for the Study of Sepsis
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05897801
- Sponsor's protocol ID
- CRONUS
- Acronym
- CRONUS
- Status last verified
- Mar 2024
- First submitted
- 22 May 2023
- Last updated
- 6 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05897801
- Acronym / sponsor ID
- CRONUS / CRONUS
- Conditions
- Viral Infection, Bacterial Infections, Multi-antibiotic Resistance, Respiratory Tract Infections
- Keywords
- Infections, Gut colonization, Respiratory track infections
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 230 participants (actual)
- Lead sponsor
- Hellenic Institute for the Study of SepsisUniversity, hospital or other
- Study start
- 29 May 2023 (actual)
- Primary completion
- 18 Dec 2023 (actual)
- Study completion
- 31 Jan 2024 (actual)
- First posted
- 9 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with a respiratory tract infection | – | Diagnostic Test: MeMed BV®Patients entering the emergency department of the sites, presenting with symptoms compatible with the diagnosis of respiratory tract infection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (9 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Diagnostic test | Patients with a respiratory tract infection |
Primary outcome
The change of the physicians decisions for the prescribed treatment based on the MeMed BV® test
Time frame: Through study completion, an average of 1 year
The change of the physicians decisions for the prescribed treatment based on the MeMed BV® test
2 secondary outcomes
The accurate prediction of the viral or the bacterial infection a patient is suffering from using the MeMed BV® test
Time frame: Through study completion, an average of 1 year
Exploratory endpoint
Time frame: Through study completion, an average of 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Evangelos Giamarellos-Bourboulis, MD,PhD study chair
Hellenic Institute for the Study of Sepsis
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Viral Infection and Bacterial Infections, run by Hellenic Institute for the Study of Sepsis at 3 sites in Greece.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 6 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Greece. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The change of the physicians decisions for the prescribed treatment based on the MeMed BV® test (time frame: Through study completion, an average of 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2024.