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Clinical Trials/NCT04976829
NCT04976829
Unknown
Not Applicable

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

Central Hospital, Nancy, France0 sites100,000 target enrollmentSeptember 1, 2021

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Antibiotic
Sponsor
Central Hospital, Nancy, France
Enrollment
100000
Primary Endpoint
Prescription rate of all systemic antibiotics
Last Updated
4 years ago

Overview

Brief Summary

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.

Registry
clinicaltrials.gov
Start Date
September 1, 2021
End Date
September 1, 2022
Last Updated
4 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

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

Exclusion Criteria

  • The paediatric and gynaeco-obstetric departments

Outcomes

Primary Outcomes

Prescription rate of all systemic antibiotics

Time Frame: 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.

Secondary Outcomes

  • 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)

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