Clinical trial NCT04976829: Evaluating Antibiotic Stewardship Assisted by Computer in the University Hospital of Nancy (MACABAO)
Official title: Evaluating Antibiotic Stewardship and Healthcare-associated Infections Surveillance Assisted by Computer in the University Hospital of Nancy
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Antibiotic
Healthcare Associated Infection
Keywords: Antibiotic stewardship
Healthcare associated infection
Clinical decision support
Interrupted time series
Infection prevention and control
Antibiotic resistance
Lead sponsor: Central Hospital, Nancy, France
Sponsor class: OTHER
First posted: 2021-07-26
Enrollment: 100000
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Nancy University Hospital (France) is a 1 497-bed tertiary-care hospital including two main geographical sites. In 2017, the point prevalence on one single day of patients treated with antibiotics was 24.4% and the prevalence of HCAI was 7.8% in this University Hospital. And the total antibiotic consumption was 591 DDD/1 000 hospital days.

The study includes the inpatients of hospital departments of medicine (intensive care, cardiology, hepato-gastro-enterology, haematology, pneumology, infectious diseases, neurology, ...), surgery, long-term care, and rehabilitation care.

All inpatients ≥ 18 years and hospitalised ≥ 48h in Nancy University Hospital will be considered in the study.

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.


Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* The paediatric and gynaeco-obstetric departments

Primary outcomes:
measure: Prescription rate of all systemic antibiotics
timeFrame: Calculated monthly during a 12-month before and 12-month after period
Secondary outcomes:
measure: All-cause intra-hospital mortality rate
timeFrame: Calculated monthly during a 12-month before and 12-month after period
measure: Average length of stay
timeFrame: Calculated monthly during a 12-month before and 12-month after period
measure: Incidence of healthcare associated infections
timeFrame: Calculated monthly during a 12-month before and 12-month after period
measure: Use of overall antibiotics and by therapeutic classes
timeFrame: Calculated monthly during a 12-month before and 12-month after period
measure: Proportion of the antibiotic prescriptions compliant with guidelines
timeFrame: Calculated monthly during a 12-month before and 12-month after period
measure: Proportion of the additional precaution prescriptions compliant with hospital recommendations
timeFrame: Calculated monthly during a 12-month before and 12-month after period
measure: Proportion of C. difficile infections
timeFrame: Calculated monthly during a 12-month before and 12-month after period
measure: Proportion of multidrug resistant bacteria identification
timeFrame: Calculated monthly during a 12-month before and 12-month after period
measure: Hospital costs
timeFrame: During the 12-month after period
measure: Users' satisfaction and acceptability
timeFrame: During the 12-month after period
Other outcomes:
Locations:
Study officials:
affiliation: Université de Lorraine, CHRU-Nancy, APEMAC EA4360, F-54000 Nancy, France
name: Arnaud Florentin, Dr
role: PRINCIPAL_INVESTIGATOR
References:
citation: Baudet A, Agrinier N, Charmillon A, Pulcini C, Lozniewski A, Aissa N, Lizon J, Thilly N, Demore B, Florentin A. Evaluating antibiotic stewardship and healthcare-associated infections surveillance assisted by computer: protocol for an interrupted time series study. BMJ Open. 2022 Apr 5;12(4):e056125. doi: 10.1136/bmjopen-2021-056125.