- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05876598
BACTERIUM: Study for a Machine-learning-based Model to Predict Bloodstream Infections (BACTERIUM)
May 24, 2023 updated by: Fondazione Policlinico Universitario Agostino Gemelli IRCCS
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 Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Observational
Enrollment (Estimated)
5000
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: rita murri
- Phone Number: 003930154945
- Email: rita.murri@policlinicogemelli.it
Study Locations
-
-
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Rome, Italy, 00168
- Recruiting
- Fondazione Policlinico Agostino Gemelli IRCCS
-
Contact:
- RITA MURRI
- Phone Number: 00390639154945
- Email: rita.murri@policlinicogemelli.it
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
No
Sampling Method
Probability Sample
Study Population
adult patients hospitalized at the Gemelli Polyclinic Foundation
Description
Inclusion Criteria:
- adult patients hospitalized at the Gemelli Polyclinic Foundation
- having at least one performed blood culture
- starting an antibiotic therapy
Exclusion Criteria:
- blood cultures with contaminants
- <18 years old
- died after less than 48 hours from blood cultures positivity
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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"
|
24 months
|
Blood cultures
Time Frame: 24 months
|
number of blood cultures done before and after the application of the predictive model "Bacterium"
|
24 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
November 3, 2021
Primary Completion (Estimated)
June 15, 2025
Study Completion (Estimated)
December 30, 2025
Study Registration Dates
First Submitted
March 16, 2023
First Submitted That Met QC Criteria
May 24, 2023
First Posted (Actual)
May 25, 2023
Study Record Updates
Last Update Posted (Actual)
May 25, 2023
Last Update Submitted That Met QC Criteria
May 24, 2023
Last Verified
March 1, 2023
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BACTERIUM-4407
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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