Antimicrobial StewardshipRF-net2018NCT06388278
Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia (RF-net2018)
An observational study of Antimicrobial Stewardship and Cost-effectiveness Analysis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico at 1 site in Italy.
Trial summary
Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: "RF-net2018" is a prospective, experimental, multicenter, pre-post study, whose objectives are the evaluation of the efficiency of economic resources allocated to the antimicrobial stewardship program (AMS) in patients with… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antimicrobial Stewardship, Cost-effectiveness Analysis
- How many people
- 50,000 participants
- Where
- 1 siteItaly
- Study dates
- 1 Mar 2023to 15 Apr 2025
- 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: Study population for different objectives are: * For Objective 1 and 3: All hospitalizations of subjects aged 18 years or older whose Hospital Discharge Form (SDO) contains at least one ICD-9-CM code that belongs to the list of codes that identify hospitalizations that likely included the administration of antimicrobial therapy (ongoing consensus activity) * For Objective 2: Subgroup of the population included for objectives 1 and 3 in which bacteremia due to carbapenem-resistant bacteria has been identified
Who may be able to join
- All hospitalizations of subjects aged 18 years or older whose Hospital Discharge Form (SDO) contains at least one ICD-9-CM code that belongs to the list of codes that identify hospitalizations that likely included the administration of antimicrobial therapy
- Subgroup of the population included for objectives 1 and 3 in which bacteremia due to carbapenem-resistant bacteria has been identified
Who cannot join
- patients non included in Inclusion criteria
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
IRCCS Fondazione Policlinico of Milan
Milan, 20135
GIULIA dr RENISI, Doctor, 3887429609, giulia.renisi@policlinico.mi.it
Alessandra dr Bandera, Doctor, 0255034770, alessandra.bandera@unimi.it
About this study
Official title: Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia: "Finalizzata di Rete 2018"
Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: "RF-net2018" is a prospective, experimental, multicenter, pre-post study, whose objectives are the evaluation of the efficiency of economic resources allocated to the antimicrobial stewardship program (AMS) in patients with infection and in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria, identified in a network of 18 hospital facilities participating in our study. Moreover, this study aims to compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. The study will include two main phases of analysis: the pre-intervention-phase and the intervention phase, both of 6 months duration. The pre-intervention phase will serve as a control for the intervention phase. The intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include a group of activities listed above (Hospital commitment, Tracking and reporting, Action and Education). Data source and analysis for the cost-effectiveness analysis, using month-department as statistical unit, are regional data: Discharge record ICD-9 codes (identification of target population 1, 2, 3, average days of hospitalization and mortality), R file (for antibiotic drug consumption month-ward) and Microbio (identification of target population 2, CR-GN and MRSA bacteremia and Cases of C. difficile infection). For what concerns healthcare costs data, each Management control office of the 18 facilities has to provide: AVERAGE HOSPITALISATION DAYS, NUMBER OF HOSPITALIZED AND TRANSFERRED PATIENTS and HEALTHCARE COSTS (healthcare personnel, diagnostic services, surgical interventions and consumption of operating rooms).
Read the detailed description
Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: "Finalizzata di Rete 2018" is a prospective, experimental, multicenter, pre-post study. The objectives of this study are:
- Objective 1: evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection. These patients will be identified in a network of 18 hospital facilities participating in our study
- Objective 2: evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria. These patients will be identified in a network of 18 hospital facilities participating in our study
- Objective 3: compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project
Study population for different objectives are:
- For Objective 1 and 3: All hospitalizations of subjects aged 18 years or older whose Hospital Discharge Form (SDO) contains at least one ICD-9-CM code that belongs to the list of codes that identify hospitalizations that likely included the administration of antimicrobial therapy (ongoing consensus activity)
- For Objective 2: Subgroup of the population included for objectives 1 and 3 in which bacteremia due to carbapenem-resistant bacteria has been identified
The study will include two main phases of analysis:
- The pre-intervention-phase (6 months)
- The intervention-phase (6 months)
The pre-intervention phase will serve as a control for the intervention phase and the unit of measurement used is month-department
Intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include:
⦁ HOSPITAL COMMITMENT : A. Definition of an official group of specialists responsible for antimicrobial stewardship activities (infectious diseases specialist, IPC referent, pharmacist e microbiologist).
- Presence of a multidisciplinary reference team that includes representatives from other medical specialties (in addition to the figures reported in point A.)
⦁ TRACKING AND REPORTING A. Monitoring the quality/adequacy of antimicrobial use at the unit and/or hospital level by hospital management B. Control of the quantity of antimicrobials prescribed/dispensed/purchased at unit level and/or hospital level by hospital management C. Monthly/bimonthly/quarterly/half-yearly report of antibiotic consumption for each department with circulation of these reports at intra-hospital level.
- Monthly/bimonthly/quarterly/semiannual reporting of cases of C. difficile infection, carbapenem-resistant gram negative bacteria isolated from blood cultures and methicillin-resistant S.aureus (MRSA) with subsequent circulation of these reports at intra-hospital level.
- ACTION A. Infectious disease review of carbapenem prescription (in any form) B. Ward rounds focusing on infection management or antibiotic prescribing in departments in your hospital
- EDUCATION A. Training events aimed at medical and nursing healthcare personnel with a focus on the use of antibiotics belonging to the carbapenem family and on controlling the spread of multidrug-resistant (MDR) microorganisms
- Keywords
- antimicrobial stewardship, cost-effectiveness analysis
What is being measured
The primary outcome is the main question the study is designed to answer.
evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection
evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection. These patients will be identified in a network of 18 hospital facilities participating in our study
Measured: 12 months
evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria.
evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria. These patients will be identified in a network of 18 hospital facilities participating in our study
Measured: 12 months
compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project
compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. These patients will be identified in a network of 18 hospital facilities participating in our study
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2024
- Study start1 Mar 2023
- Primary completion1 Nov 2024 (estimated)
- Study completion15 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Antimicrobial StewardshipStudies of the same condition, open and under way.
- More trials run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoThe sponsor's other registered studies.
- 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
- Other
- Time perspective
- Prospective
- Enrolment
- 50,000 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Regione Lombardia, Ministero della Salute, Italy
- Responsible party
- Principal investigator, malattie_infettive, Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico
- Investigators
- Andrea Gori, Principal investigator, IRCCS Fondazione Cà Granda Policlinico of Milan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06388278
- Sponsor's protocol ID
- NET-2018-12366982-4/ASP_LOMB
- Acronym
- RF-net2018
- Status last verified
- Apr 2024
- First submitted
- 24 Apr 2024
- Last updated
- 29 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cost-effectiveness Analysis of an Antimicrobial Stewardship Program in Regione Lombardia: "Finalizzata di Rete 2018"
- ClinicalTrials.gov ID
- NCT06388278
- Acronym / sponsor ID
- RF-net2018 / NET-2018-12366982-4/ASP_LOMB
- Keywords
- antimicrobial stewardship, cost-effectiveness analysis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 50,000 participants (estimated)
- Lead sponsor
- Fondazione IRCCS Ca' Granda, Ospedale Maggiore PoliclinicoUniversity, hospital or other
- Collaborators
- Regione Lombardia, Ministero della Salute, Italy
- Study start
- 1 Mar 2023 (actual)
- Primary completion
- 1 Nov 2024 (estimated)
- Study completion
- 15 Apr 2025 (estimated)
- First posted
- 29 Apr 2024 (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.
Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: "RF-net2018" is a prospective, experimental, multicenter, pre-post study, whose objectives are the evaluation of the efficiency of economic resources allocated to the antimicrobial stewardship program (AMS) in patients with infection and in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria, identified in a network of 18 hospital facilities participating in our study. Moreover, this study aims to compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. The study will include two main phases of analysis: the pre-intervention-phase and the intervention phase, both of 6 months duration. The pre-intervention phase will serve as a control for the intervention phase. The intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include a group of activities listed above (Hospital commitment, Tracking and reporting, Action and Education). Data source and analysis for the cost-effectiveness analysis, using month-department as statistical unit, are regional data: Discharge record ICD-9 codes (identification of target population 1, 2, 3, average days of hospitalization and mortality), R file (for antibiotic drug consumption month-ward) and Microbio (identification of target population 2, CR-GN and MRSA bacteremia and Cases of C. difficile infection). For what concerns healthcare costs data, each Management control office of the 18 facilities has to provide: AVERAGE HOSPITALISATION DAYS, NUMBER OF HOSPITALIZED AND TRANSFERRED PATIENTS and HEALTHCARE COSTS (healthcare personnel, diagnostic services, surgical interventions and consumption of operating rooms).
Detailed description
Cost-effectiveness analysis of an Antimicrobial Stewardship program in Regione Lombardia: "Finalizzata di Rete 2018" is a prospective, experimental, multicenter, pre-post study. The objectives of this study are:
- Objective 1: evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection. These patients will be identified in a network of 18 hospital facilities participating in our study
- Objective 2: evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria. These patients will be identified in a network of 18 hospital facilities participating in our study
- Objective 3: compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project
Study population for different objectives are:
- For Objective 1 and 3: All hospitalizations of subjects aged 18 years or older whose Hospital Discharge Form (SDO) contains at least one ICD-9-CM code that belongs to the list of codes that identify hospitalizations that likely included the administration of antimicrobial therapy (ongoing consensus activity)
- For Objective 2: Subgroup of the population included for objectives 1 and 3 in which bacteremia due to carbapenem-resistant bacteria has been identified
The study will include two main phases of analysis:
- The pre-intervention-phase (6 months)
- The intervention-phase (6 months)
The pre-intervention phase will serve as a control for the intervention phase and the unit of measurement used is month-department
Intervention phase is represented by antimicrobial stewardship activities which have been implemented in the network of 18 hospital facilities and that include:
⦁ HOSPITAL COMMITMENT : A. Definition of an official group of specialists responsible for antimicrobial stewardship activities (infectious diseases specialist, IPC referent, pharmacist e microbiologist).
- Presence of a multidisciplinary reference team that includes representatives from other medical specialties (in addition to the figures reported in point A.)
⦁ TRACKING AND REPORTING A. Monitoring the quality/adequacy of antimicrobial use at the unit and/or hospital level by hospital management B. Control of the quantity of antimicrobials prescribed/dispensed/purchased at unit level and/or hospital level by hospital management C. Monthly/bimonthly/quarterly/half-yearly report of antibiotic consumption for each department with circulation of these reports at intra-hospital level.
- Monthly/bimonthly/quarterly/semiannual reporting of cases of C. difficile infection, carbapenem-resistant gram negative bacteria isolated from blood cultures and methicillin-resistant S.aureus (MRSA) with subsequent circulation of these reports at intra-hospital level.
- ACTION A. Infectious disease review of carbapenem prescription (in any form) B. Ward rounds focusing on infection management or antibiotic prescribing in departments in your hospital
- EDUCATION A. Training events aimed at medical and nursing healthcare personnel with a focus on the use of antibiotics belonging to the carbapenem family and on controlling the spread of multidrug-resistant (MDR) microorganisms
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population for different objectives are: * For Objective 1 and 3: All hospitalizations of subjects aged 18 years or older whose Hospital Discharge Form (SDO) contains at least one ICD-9-CM code that belongs to the list of codes that identify hospitalizations that likely included the administration of antimicrobial therapy (ongoing consensus activity) * For Objective 2: Subgroup of the population included for objectives 1 and 3 in which bacteremia due to carbapenem-resistant bacteria has been identified
Key inclusion criteria (2 listed)
- All hospitalizations of subjects aged 18 years or older whose Hospital Discharge Form (SDO) contains at least one ICD-9-CM code that belongs to the list of codes that identify hospitalizations that likely included the administration of antimicrobial therapy
- Subgroup of the population included for objectives 1 and 3 in which bacteremia due to carbapenem-resistant bacteria has been identified
Key exclusion criteria (1 listed)
- patients non included in Inclusion criteria
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection
Time frame: 12 months
evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection. These patients will be identified in a network of 18 hospital facilities participating in our study
evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria.
Time frame: 12 months
evaluate the efficiency of the economic resources allocated to the AMS program through a cost-effectiveness analysis in patients with infections caused by carbapenem-resistant gram-negative (CR-GN) bacteria. These patients will be identified in a network of 18 hospital facilities participating in our study
compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project
Time frame: 12 months
compare hospital mortality among patients admitted to the facilities participating in the study before and during the implementation of the AMS project. These patients will be identified in a network of 18 hospital facilities participating in our study
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Apr 2024.
- Individual participant dataSharing planned: Undecided
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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.
Andrea Gori principal investigator
IRCCS Fondazione Cà Granda Policlinico of Milan
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 Antimicrobial Stewardship and Cost-effectiveness Analysis, run by Fondazione IRCCS Ca' Granda, Ospedale Maggiore Policlinico 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 2 inclusion and 1 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: status not confirmed, as of the sponsor's last update on 29 Apr 2024. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact GIULIA RENISI (+393887429609, clinicaltrial.malinf@policlinico.mi.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
evaluate the efficiency of the economic resources allocated to the antimicrobial stewardship program (AMS) through a cost-effectiveness analysis in patients with infection (time frame: 12 months). The study lists 3 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 29 Apr 2024.