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临床试验/NCT04976829
NCT04976829Unknown不适用

Evaluating Antibiotic Stewardship and Healthcare-associated Infections Surveillance Assisted by Computer in the University Hospital of Nancy

Central Hospital, Nancy, France0 个研究点目标入组 100,000 人开始时间: 2021年9月1日最近更新:
适应症

试验速览

阶段
不适用
发起方
入组人数
100,000
主要终点
Prescription rate of all systemic antibiotics

研究概览

简要总结

Antibiotic resistance is one of the most pressing health threats that mankind faces now and in the coming decades. Antibiotic resistance leads to longer hospital stays, higher medical costs and increased mortality. In order to tackle antibiotic resistance, a computerized-decision support system (CDSS) facilitating antibiotic stewardship and an electronic surveillance software (ESS) facilitating infection prevention and control activities will implement in our tertiary care university hospital.

The investigators conduct a pragmatic, prospective, single-centre, before-after uncontrolled study with an interrupted time-series analysis 12 months before and 12 months after the introduction of the CDSS for antibiotic stewardship (APSS) and ESS for infection surveillance (ZINC). APSS and ZINC will assist respectively the antibiotic stewardship and the infection prevention and control teams of Nancy University Hospital (France). The investigators will evaluate the impact of the CDSS/ESS on the antibiotic use in adult (≥ 18 years) inpatients (hospitalised ≥ 48h). The primary outcome is the prescription rate by all healthcare professionals from the hospital of all systemic antibiotics expressed in defined daily doses/1 000 patients/month. Concurrently, the investigators will assess the safety of the intervention, its impact on the appropriateness of antibiotic prescriptions and on additional precautions (isolation precautions) as recommended in guidelines, and on bacterial epidemiology (multidrug-resistant bacteria and Clostridioides difficile infections) in the hospital. Finally, the investigators will evaluate the users' satisfaction and the cost of this intervention from the hospital perspective.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Other

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 inpatients ≥ 18 years and hospitalised ≥ 48h in Nancy University Hospital

排除标准

  • The paediatric and gynaeco-obstetric departments

结局指标

主要结局

Prescription rate of all systemic antibiotics

时间窗: Calculated monthly during a 12-month before and 12-month after period

The prescription rate by all healthcare professionals from the Nancy University Hospital of all systemic antibiotics (J01 code according to the Anatomical Therapeutic Chemical - ATC - 2017 classification) expressed in DDDs/1 000 patients/month.

次要结局

  • All-cause intra-hospital mortality rate(Calculated monthly during a 12-month before and 12-month after period)
  • Proportion of the antibiotic prescriptions compliant with guidelines(Calculated monthly during a 12-month before and 12-month after period)
  • Proportion of C. difficile infections(Calculated monthly during a 12-month before and 12-month after period)
  • Proportion of multidrug resistant bacteria identification(Calculated monthly during a 12-month before and 12-month after period)
  • Users' satisfaction and acceptability(During the 12-month after period)
  • Average length of stay(Calculated monthly during a 12-month before and 12-month after period)
  • Incidence of healthcare associated infections(Calculated monthly during a 12-month before and 12-month after period)
  • Proportion of the additional precaution prescriptions compliant with hospital recommendations(Calculated monthly during a 12-month before and 12-month after period)
  • Hospital costs(During the 12-month after period)
  • Use of overall antibiotics and by therapeutic classes(Calculated monthly during a 12-month before and 12-month after period)

研究者

发起方
Central Hospital, Nancy, France
申办方类型
Other
责任方
Sponsor

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