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临床试验/NCT05813821
NCT05813821已完成不适用

Evaluation of a National Antibiotic Stewardship Intervention (7-VINCut) to Decrease the Duration of Antibiotic Treatment and Carbapenem Use in Surgical Services

Hospital de Granollers2 个研究点 分布在 1 个国家目标入组 32,499 人开始时间: 2019年1月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
发起方
入组人数
32,499
试验地点
2
主要终点
Patients subjected to more than 7 days of antibiotic therapy

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Prevention
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • All patients hospitalized in the targeted surgical departments

排除标准

  • 未提供

结局指标

主要结局

Patients subjected to more than 7 days of antibiotic therapy

时间窗: One week

Percentage of patients subjected to more than 7 days of antibiotic therapy in surgical departments

次要结局

  • Type of infection(One week)
  • Compliance with recommendations issued by stewardship teams(2 days after recommendation)
  • Quality of control of septic focus(Two days)

研究者

发起方
Hospital de Granollers
申办方类型
Other
责任方
Principal Investigator
主要研究者

Josep Maria Badia

Prof

Hospital de Granollers

研究点 (2)

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