Infection, BloodstreamBACTERIUMNCT05876598
BACTERIUM: Study for a Machine-learning-based Model to Predict Bloodstream Infections
An observational study of Infection, Bloodstream, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
Trial summary
An increase of healthcare-associated infections caused by multidrug- resistant organisms (MRDO) is currently observed. One of the main causes of the emergence of a MDRO infection is an overuse of antibiotics. Therefore, saving useless antibiotic treatment is currently a priority from a public health point of view. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Infection, Bloodstream
- What is being tested?
- antibiotic treatments
- How many people
- 5,000 participants
- Where
- 1 siteItaly
- Study dates
- 3 Nov 2021to 30 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: adult patients hospitalized at the Gemelli Polyclinic Foundation
Who may be able to join
- adult patients hospitalized at the Gemelli Polyclinic Foundation
- having at least one performed blood culture
- starting an antibiotic therapy
Who cannot join
- blood cultures with contaminants
- <18 years old
- died after less than 48 hours from blood cultures positivity
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
Fondazione Policlinico Agostino Gemelli Irccs
Rome, 00168
RITA MURRI, 00390639154945, rita.murri@policlinicogemelli.it
About this study
An increase of healthcare-associated infections caused by multidrug- resistant organisms (MRDO) is currently observed. One of the main causes of the emergence of a MDRO infection is an overuse of antibiotics. Therefore, saving useless antibiotic treatment is currently a priority from a public health point of view. The evaluation of the risk of having a bloodstream infection will allow both activating faster treatment decisions (when the risk is significantly high) or to save useless resources in terms of diagnostic tests and treatments, also limiting the potential for side effects (when the risk is significantly low).
- Conditions
- Infection, Bloodstream
- Being tested
- antibiotic treatments
- Medical subject headings
- Sepsis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
antibiotic treatmentsDrug
The outcome of the study will be to implement Prediction Models to support clinicians for the assessment of risk of having a bloodstream infection.
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of appropriate antibiotic therapy in patients with bloodstream infections
- number of patients with bloodstream infections with appropriate antibiotic therapy before and after the application of the predictive model "Bacterium"
Measured: 24 months
Blood cultures
number of blood cultures done before and after the application of the predictive model "Bacterium"
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start3 Nov 2021
- Primary completion15 Jun 2025 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infection, BloodstreamStudies 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
- 5,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCS
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rita Murri, Principal investigator, Fondazione Policlinico Universitario Agostino Gemelli IRCCS
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05876598
- Sponsor's protocol ID
- BACTERIUM-4407
- Acronym
- BACTERIUM
- Status last verified
- Mar 2025
- First submitted
- 16 Mar 2023
- Last updated
- 11 Mar 2025
- Results posted
- 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 11 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- BACTERIUM: Study for a Machine-learning-based Model to Predict Bloodstream Infections
- ClinicalTrials.gov ID
- NCT05876598
- Acronym / sponsor ID
- BACTERIUM / BACTERIUM-4407
- Conditions
- Infection, Bloodstream
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 5,000 participants (estimated)
- Lead sponsor
- Fondazione Policlinico Universitario Agostino Gemelli IRCCSUniversity, hospital or other
- Study start
- 3 Nov 2021 (actual)
- Primary completion
- 15 Jun 2025 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 25 May 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.
An increase of healthcare-associated infections caused by multidrug- resistant organisms (MRDO) is currently observed. One of the main causes of the emergence of a MDRO infection is an overuse of antibiotics. Therefore, saving useless antibiotic treatment is currently a priority from a public health point of view. The evaluation of the risk of having a bloodstream infection will allow both activating faster treatment decisions (when the risk is significantly high) or to save useless resources in terms of diagnostic tests and treatments, also limiting the potential for side effects (when the risk is significantly low).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- adult patients hospitalized at the Gemelli Polyclinic Foundation
Key inclusion criteria (3 listed)
- adult patients hospitalized at the Gemelli Polyclinic Foundation
- having at least one performed blood culture
- starting an antibiotic therapy
Key exclusion criteria (3 listed)
- blood cultures with contaminants
- <18 years old
- died after less than 48 hours from blood cultures positivity
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 |
|---|---|---|
| antibiotic treatmentsThe outcome of the study will be to implement Prediction Models to support clinicians for the assessment of risk of having a bloodstream infection. | Drug | – |
Primary outcome
Rate of appropriate antibiotic therapy in patients with bloodstream infections
Time frame: 24 months
1) number of patients with bloodstream infections with appropriate antibiotic therapy before and after the application of the predictive model "Bacterium"
Blood cultures
Time frame: 24 months
number of blood cultures done before and after the application of the predictive model "Bacterium"
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Mar 2025.
- 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.
Rita Murri principal investigator
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infection, Bloodstream, run by Fondazione Policlinico Universitario Agostino Gemelli IRCCS at 1 site in Italy.
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 3 inclusion and 3 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: looking for participants now, as of the sponsor's last update on 11 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact rita murri (003930154945, rita.murri@policlinicogemelli.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of appropriate antibiotic therapy in patients with bloodstream infections (time frame: 24 months). The study lists 2 primary outcomes in all. 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 11 Mar 2025.