7-VINCut Antibiotic Stewardship Intervention to Decrease Duration of Antibiotic Treatment and Carbapenem Use in Surgery

NCT05813821 | Completed

• 1 other identifier: HGG2022_01
• Study Type: interventional
• Target: 32,499
• Locations: 1 country
• Sites: 1

Brief 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. 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.

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

Outcome Measures

Primary Outcomes (1)

• 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

  One week

Secondary Outcomes (3)

• Compliance with recommendations issued by stewardship teams

  2 days after recommendation

• Type of infection

  One week

• Quality of control of septic focus

  Two days

Study Arms (1)

Patients with antibiotic treatment in surgical departments

EXPERIMENTAL

All patients admitted for antibiotic treatment in the surgical departments of the participating centres were included.

Behavioral: Antimicrobial stewardship in surgery

Interventions

Antimicrobial stewardship in surgery BEHAVIORAL

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.

Patients with antibiotic treatment in surgical departments

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• All patients hospitalized in the targeted surgical departments

You may not qualify if:

• None

Sponsors & Collaborators

• Hospital de Granollers: lead

Study Sites (1)

Hospital General de Granollers

Granollers, Barcelona, 08402, Spain

Location

MeSH Terms

Conditions

Medication Adherence

Interventions

Antimicrobial Stewardship; Surgical Procedures, Operative

Condition Hierarchy (Ancestors)

Patient Compliance; Patient Acceptance of Health Care; Treatment Adherence and Compliance; Health Behavior; Behavior

Intervention Hierarchy (Ancestors)

Drug Utilization Review; Drug Utilization; Pharmacy Administration; Organization and Administration; Health Services Administration; Utilization Review; Quality of Health Care; Quality Assurance, Health Care; Health Care Quality, Access, and Evaluation

Study Officials

• Josep M Badia

  Hospital General de Granollers

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof

Model Details: Multicenter, prospective, interventional, cohort study analysing the effect of an antimicrobial stewardship intervention in surgery.

Study Record Dates

• First Submitted: March 30, 2023
• First Posted: April 14, 2023
• Study Start: January 1, 2019
• Primary Completion: December 31, 2021
• Study Completion: December 31, 2021
• Last Updated: April 14, 2023

Record last verified: 2023-04

Locations

ES (1)