Medication Adherence7_VINCUTNCT05813821
7-VINCut Antibiotic Stewardship Intervention to Decrease Duration of Antibiotic Treatment and Carbapenem Use in Surgery
A study testing Antimicrobial stewardship in surgery in people with Medication Adherence and Antibiotic Resistance, Microbial, run by Hospital de Granollers at 1 site in Spain.
Trial summary
Antimicrobial resistance (AMR) is one of the top ten public health threats facing humanity. The misuse and overuse of antibiotics has been identified as a major factor in the development of drug-resistant pathogens, and 30% of all antimicrobials administered in Western acute hospitals are unnecessary or inappropriate. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Medication Adherence, Antibiotic Resistance, Microbial, Medication Errors and Other Product Use Errors and Issues
- What is being tested?
- Antimicrobial stewardship in surgery
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32,499 participants
- Where
- 1 siteSpain
- Study dates
- 1 Jan 2019to 31 Dec 2021
- Phase
- Interventional
- 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
Who may be able to join
- All patients hospitalized in the targeted surgical departments
Who cannot join
- None
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of a National Antibiotic Stewardship Intervention (7-VINCut) to Decrease the Duration of Antibiotic Treatment and Carbapenem Use in Surgical Services
Antimicrobial resistance (AMR) is one of the top ten public health threats facing humanity. The misuse and overuse of antibiotics has been identified as a major factor in the development of drug-resistant pathogens, and 30% of all antimicrobials administered in Western acute hospitals are unnecessary or inappropriate. As a consequence, the establishment of antimicrobial stewardship programmes (ASPs) has increased in hospitals over the past decades.
Using ASPs to optimise antimicrobial use is critical to effectively fight infections, protect patients and reduce AMR. ASPs can increase infection cure rates while reducing AMR, but it has been reported that few of them are specifically targeted at surgical specialties or led by surgeons.
Read more
Surgeons are actively involved in antibiotic prescribing and should therefore play an important role in the development and leadership of ASPs in surgical departments.
Practice Guidelines have established recommendations for the wise use of antibiotics in patients affected by intra-abdominal infection: early identification of sepsis, early initiation of antimicrobial therapy and early control of the infectious focus. The literature on the optimal duration of antibiotic treatment in surgery is sparse, but it seems that, if the septic source has been effectively controlled, short courses of treatment show the same results as longer courses.Compliance rates with the suggested duration of treatment in evidence-based guidelines are low among the surgical community.
No specially designed ASPs for the reduction of treatment duration in surgery have been reported. ASPs may be easy to introduce in a single hospital, but the feasibility of a nationwide implementation of ASPs in a large and diverse hospital population is unclear.
This prospective, interventional, cohort study was aimed: to reduce the duration of antimicrobial treatment in surgical departments by modifying their prescriptions through educational and consensual interventions; and to assess the feasibility of implementing a multi-centre ASP, leveraging a nationwide surveillance programme for healthcare-associated infection.
It was hypothesised that a coordinated and guided implementation strategy, organised within a consolidated infection surveillance network, would lead to the successful implementation of the ASP and reduce antibiotic consumption in participating hospitals.
Read the detailed description
This is a multicenter, prospective, interventional, cohort study analysing the effect of an antimicrobial stewardship intervention in surgery. The study uses data collected prospectively leveraging an infection surveillance network.
4.1. Setting and patients. The 7VINCut antibiotic stewardship program started in 2019 at national level to shorten the duration of antibiotic therapy in adult patients admitted to surgical departments. Secondary objectives were to reduce the consumption of carbapenems in surgical services and to reduce the consumption of other antibiotics with ecological impact (piperacillin-tazobactam, amoxicillin/clavulanate, 3rd and 4th generation cephalosporins and quinolones).
The prospective study was conducted between January 2019 and December 2022. Data from 32 hospitals participating in the network were included in the analysis.
All patients aged 18 years or older admitted to general and urological surgical services, who received systemic antibiotic treatments lasting for 7 or more days were included. Patients with antibiotics prescribed for surgical prophylaxis were excluded. Because to the characteristics of the infections treated in Orthopedics and Vascular Surgery departments, often requiring long-term treatments, the cases with diseases specific to these services (osteomyelitis, diabetic foot, etc) were excluded.
4.2. Intervention. The intervention started with the dissemination of the project protocol to all hospitals participating in the network, and a workshop for surgical and infection control teams. This was a multidisciplinary project in which hospitals were invited to form a specific surgical ASP with surgeons, pharmacists and infectious disease specialists. Participating institutions established local teams with the support of senior hospital leaders to facilitate the implementation of the ASP.
The interventional ASP relied on an audit and feedback strategy to issue recommendations aimed at reducing the duration of antibiotic treatment regimens and reducing the use of drugs with a particular impact on microbial ecology.
All patients hospitalized in the targeted departments were prospectively analyzed weekly. A computerized alert allowed the ASP team to identify those patients whose antibiotic treatment lasted longer than 7 days. The team meet to discuss the appropriateness of each antibiotic treatment, issuing a written recommendation for each patient. The intervention was performed only once for each patient, except if they had a new focus of infection. The recommendations available for prolonged treatments were: withdraw, maintain, de-escalate, broaden, change route, optimize dose, no recommendation. The recommendations were discussed in the Surgery Departments and implemented if deemed necessary. Adherence to the recommendations was recorded 48 hours later by the ASP team.
Although the intervention focused on the duration of antibiotic treatment, the stewardship team added recommendations on the microbiological appropriateness of the treatments and the use of broad-spectrum antibiotics, especially carbapenems. Before implementation of the program in the hospital, a series of educational initiatives related to antibiotic management in the Department of Surgery were introduced.
The prescriptions analyzed were either pathogen directed or empirical broad spectrum antibiotic treatments. Before making the ASP recommendations, the microbiological results were reviewed, when available. The appropriateness of the empirical antibiotics prescribed according to the hospital antibiotic guideline was also reviewed.
The main outcome evaluated was the percentage of patients subjected to more than 7 days of antibiotic therapy. Other outcomes were: percentage of new patients on antibiotic treatment >7 days out of the total number of patients on antibiotic treatment admitted to the surgical services; percentage of adherence to recommendations.
Variables such as type of infection, quality of control of infectious focus (good, uncertain, bad) for which antibiotic treatment was indicated was reported, use of broad spectrum antibiotics, route of administration, and microbiological adequacy have been analyzed.
4.3. Ethics and statistics. The study was approved by the Research Ethics Committee of the Hospital General Universitari de Granollers with code 20222042, which did not consider an informed consent document necessary. The project will be reported according to the "Strengthening the reporting of cohort, cross-sectional and case-control studies in surgery" (STROCSS 2021) criteria.
Data was entered into a computerized database that was analyzed using the IBM SPSS program (v. 21.0, Chicago, IL, USA). The evolution of the percentage of new patients undergoing a prolonged antibiotic treatment related to the total number of patients on antibiotic treatment has been evaluated by simple linear regression. The linear relationship was tested by ANOVA tests and Pearson's correlation coefficients (Pc) were obtained. Values of p ≤ 0.05 were considered statistically significant. A bilateral distribution was assumed for all p values.
- Conditions
- Medication Adherence, Antibiotic Resistance, Microbial, Medication Errors and Other Product Use Errors and Issues
- Being tested
- Antimicrobial stewardship in surgery
- Keywords
- Anti-Bacterial Agents / therapeutic use, Infection Control / organization & administration, Antimicrobial Stewardship / organization & administration, Antimicrobial Stewardship / statistics & numerical data, General Surgery / standards
- Medical subject headings
- Medication Adherence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antimicrobial stewardship in surgeryBehavioural
Hospitals were invited to form a surgical antibiotic stewardship program (ASP) with surgeons, pharmacists and infectious disease specialists. The interventional ASP relied on an audit and feedback strategy to issue recommendations aimed at reducing the duration of antibiotic treatment and the use of drugs with a particular impact on microbial ecology.
All patients hospitalized in surgical departments were prospectively analyzed weekly. A computerized alert allowed the ASP team to identify patients with antibiotic treatment >7 days. The team meet to discuss the appropriateness of each antibiotic treatment, issuing a written recommendation for each patient. The intervention was performed only once for each patient, except if they had a new focus of infection. The recommendations available for prolonged treatments were: withdraw, maintain, de-escalate, broaden, change route, optimize dose, no recommendation. Adherence to the recommendations was recorded 48 hours later by the ASP team.
| Study group | Role | What they receive |
|---|---|---|
| Patients with antibiotic treatment in surgical departments | Experimental | All patients admitted for antibiotic treatment in the surgical departments of the participating centres were included. Receives: Behavioral: Antimicrobial stewardship in surgery |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patients subjected to more than 7 days of antibiotic therapy
Percentage of patients subjected to more than 7 days of antibiotic therapy in surgical departments
Measured: One week
Secondary outcomes (3)
Compliance with recommendations issued by stewardship teams
The number of patients in which the recommendations of the ASP team have been followed will be analysed out of the total number of recommendations issued. This will be done by reviewing electronic medical records and calculating the percentage of compliance with the recommendations out of the total number of antibiotic treatment recommendations issued by the management team.
Measured: 2 days after recommendation
Type of infection
Type of infection for which antibiotic treatment was indicated
Measured: One week
Quality of control of septic focus
The assessment team will analyse the quality of focus control for each case, looking at the surgeon's subjective assessment at the end of the operation (recorded in the operative notes) and the clinical evolution of the patient during the first two days post-operatively. Quality shall be classified as good, uncertain or poor.
Measured: Two days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2023
- Study start1 Jan 2019
- Primary completion31 Dec 2021
- Study completion31 Dec 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Medication AdherenceStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Multicenter, prospective, interventional, cohort study analysing the effect of an antimicrobial stewardship intervention in surgery.
- Masking
- None (open label)
- Enrolment
- 32,499 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hospital de Granollers
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Josep Maria Badia, Hospital de Granollers
- Investigators
- Josep M Badia, Study director, Hospital General de Granollers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05813821
- Sponsor's protocol ID
- HGG2022_01
- Acronym
- 7_VINCUT
- Status last verified
- Apr 2023
- First submitted
- 30 Mar 2023
- Last updated
- 14 Apr 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of a National Antibiotic Stewardship Intervention (7-VINCut) to Decrease the Duration of Antibiotic Treatment and Carbapenem Use in Surgical Services
- ClinicalTrials.gov ID
- NCT05813821
- Acronym / sponsor ID
- 7_VINCUT / HGG2022_01
- Conditions
- Medication Adherence, Antibiotic Resistance, Microbial, Medication Errors and Other Product Use Errors and Issues
- Keywords
- Anti-Bacterial Agents / therapeutic use, Infection Control / organization & administration, Antimicrobial Stewardship / organization & administration, Antimicrobial Stewardship / statistics & numerical data, General Surgery / standards
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32,499 participants (actual)
- Lead sponsor
- Hospital de GranollersUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2021 (actual)
- First posted
- 14 Apr 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.
Antimicrobial resistance (AMR) is one of the top ten public health threats facing humanity. The misuse and overuse of antibiotics has been identified as a major factor in the development of drug-resistant pathogens, and 30% of all antimicrobials administered in Western acute hospitals are unnecessary or inappropriate. As a consequence, the establishment of antimicrobial stewardship programmes (ASPs) has increased in hospitals over the past decades.
Using ASPs to optimise antimicrobial use is critical to effectively fight infections, protect patients and reduce AMR. ASPs can increase infection cure rates while reducing AMR, but it has been reported that few of them are specifically targeted at surgical specialties or led by surgeons.
Surgeons are actively involved in antibiotic prescribing and should therefore play an important role in the development and leadership of ASPs in surgical departments.
Practice Guidelines have established recommendations for the wise use of antibiotics in patients affected by intra-abdominal infection: early identification of sepsis, early initiation of antimicrobial therapy and early control of the infectious focus. The literature on the optimal duration of antibiotic treatment in surgery is sparse, but it seems that, if the septic source has been effectively controlled, short courses of treatment show the same results as longer courses.Compliance rates with the suggested duration of treatment in evidence-based guidelines are low among the surgical community.
No specially designed ASPs for the reduction of treatment duration in surgery have been reported. ASPs may be easy to introduce in a single hospital, but the feasibility of a nationwide implementation of ASPs in a large and diverse hospital population is unclear.
This prospective, interventional, cohort study was aimed: to reduce the duration of antimicrobial treatment in surgical departments by modifying their prescriptions through educational and consensual interventions; and to assess the feasibility of implementing a multi-centre ASP, leveraging a nationwide surveillance programme for healthcare-associated infection.
It was hypothesised that a coordinated and guided implementation strategy, organised within a consolidated infection surveillance network, would lead to the successful implementation of the ASP and reduce antibiotic consumption in participating hospitals.
Detailed description
This is a multicenter, prospective, interventional, cohort study analysing the effect of an antimicrobial stewardship intervention in surgery. The study uses data collected prospectively leveraging an infection surveillance network.
4.1. Setting and patients. The 7VINCut antibiotic stewardship program started in 2019 at national level to shorten the duration of antibiotic therapy in adult patients admitted to surgical departments. Secondary objectives were to reduce the consumption of carbapenems in surgical services and to reduce the consumption of other antibiotics with ecological impact (piperacillin-tazobactam, amoxicillin/clavulanate, 3rd and 4th generation cephalosporins and quinolones).
The prospective study was conducted between January 2019 and December 2022. Data from 32 hospitals participating in the network were included in the analysis.
All patients aged 18 years or older admitted to general and urological surgical services, who received systemic antibiotic treatments lasting for 7 or more days were included. Patients with antibiotics prescribed for surgical prophylaxis were excluded. Because to the characteristics of the infections treated in Orthopedics and Vascular Surgery departments, often requiring long-term treatments, the cases with diseases specific to these services (osteomyelitis, diabetic foot, etc) were excluded.
4.2. Intervention. The intervention started with the dissemination of the project protocol to all hospitals participating in the network, and a workshop for surgical and infection control teams. This was a multidisciplinary project in which hospitals were invited to form a specific surgical ASP with surgeons, pharmacists and infectious disease specialists. Participating institutions established local teams with the support of senior hospital leaders to facilitate the implementation of the ASP.
The interventional ASP relied on an audit and feedback strategy to issue recommendations aimed at reducing the duration of antibiotic treatment regimens and reducing the use of drugs with a particular impact on microbial ecology.
All patients hospitalized in the targeted departments were prospectively analyzed weekly. A computerized alert allowed the ASP team to identify those patients whose antibiotic treatment lasted longer than 7 days. The team meet to discuss the appropriateness of each antibiotic treatment, issuing a written recommendation for each patient. The intervention was performed only once for each patient, except if they had a new focus of infection. The recommendations available for prolonged treatments were: withdraw, maintain, de-escalate, broaden, change route, optimize dose, no recommendation. The recommendations were discussed in the Surgery Departments and implemented if deemed necessary. Adherence to the recommendations was recorded 48 hours later by the ASP team.
Although the intervention focused on the duration of antibiotic treatment, the stewardship team added recommendations on the microbiological appropriateness of the treatments and the use of broad-spectrum antibiotics, especially carbapenems. Before implementation of the program in the hospital, a series of educational initiatives related to antibiotic management in the Department of Surgery were introduced.
The prescriptions analyzed were either pathogen directed or empirical broad spectrum antibiotic treatments. Before making the ASP recommendations, the microbiological results were reviewed, when available. The appropriateness of the empirical antibiotics prescribed according to the hospital antibiotic guideline was also reviewed.
The main outcome evaluated was the percentage of patients subjected to more than 7 days of antibiotic therapy. Other outcomes were: percentage of new patients on antibiotic treatment >7 days out of the total number of patients on antibiotic treatment admitted to the surgical services; percentage of adherence to recommendations.
Variables such as type of infection, quality of control of infectious focus (good, uncertain, bad) for which antibiotic treatment was indicated was reported, use of broad spectrum antibiotics, route of administration, and microbiological adequacy have been analyzed.
4.3. Ethics and statistics. The study was approved by the Research Ethics Committee of the Hospital General Universitari de Granollers with code 20222042, which did not consider an informed consent document necessary. The project will be reported according to the "Strengthening the reporting of cohort, cross-sectional and case-control studies in surgery" (STROCSS 2021) criteria.
Data was entered into a computerized database that was analyzed using the IBM SPSS program (v. 21.0, Chicago, IL, USA). The evolution of the percentage of new patients undergoing a prolonged antibiotic treatment related to the total number of patients on antibiotic treatment has been evaluated by simple linear regression. The linear relationship was tested by ANOVA tests and Pearson's correlation coefficients (Pc) were obtained. Values of p ≤ 0.05 were considered statistically significant. A bilateral distribution was assumed for all p values.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Multicenter, prospective, interventional, cohort study analysing the effect of an antimicrobial stewardship intervention in surgery.
| Arm | Type | Receives |
|---|---|---|
| Patients with antibiotic treatment in surgical departments | Experimental | Behavioral: Antimicrobial stewardship in surgeryAll patients admitted for antibiotic treatment in the surgical departments of the participating centres were included. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- All patients hospitalized in the targeted surgical departments
Key exclusion criteria (1 listed)
- None
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 |
|---|---|---|
| Antimicrobial stewardship in surgeryHospitals were invited to form a surgical antibiotic stewardship program (ASP) with surgeons, pharmacists and infectious disease specialists. The interventional ASP relied on an audit and feedback strategy to issue recommendations aimed at reducing the duration of antibiotic treatment and the use of drugs with a particular impact on microbial ecology. All patients hospitalized in surgical departments were prospectively analyzed weekly. A computerized alert allowed the ASP team to identify patients with antibiotic treatment >7 days. The team meet to discuss the appropriateness of each antibiotic treatment, issuing a written recommendation for each patient. The intervention was performed only once for each patient, except if they had a new focus of infection. The recommendations available for prolonged treatments were: withdraw, maintain, de-escalate, broaden, change route, optimize dose, no recommendation. Adherence to the recommendations was recorded 48 hours later by the ASP team. | Behavioural | Patients with antibiotic treatment in surgical departments |
Primary outcome
Patients subjected to more than 7 days of antibiotic therapy
Time frame: One week
Percentage of patients subjected to more than 7 days of antibiotic therapy in surgical departments
3 secondary outcomes
Compliance with recommendations issued by stewardship teams
Time frame: 2 days after recommendation
Type of infection
Time frame: One week
Quality of control of septic focus
Time frame: Two days
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 14 Apr 2023.
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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.
Josep M Badia study director
Hospital General de Granollers
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antimicrobial stewardship in surgery in people with Medication Adherence and Antibiotic Resistance, Microbial, run by Hospital de Granollers at 1 site in Spain.
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 1 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: finished, as of the sponsor's last update on 14 Apr 2023. 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 Spain. 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?
Patients subjected to more than 7 days of antibiotic therapy (time frame: One week). 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 14 Apr 2023.