Evaluating Antibiotic Stewardship Assisted by Computer in the University Hospital of Nancy (MACABAO)

• Conditions: Antibiotic; Healthcare Associated Infection
• Interventions: Device: Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer

• Registration Number: NCT04976829
• Lead Sponsor: Central Hospital, Nancy, France

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2021-07
• Study First Submitted: 2021-07-15
• Study First Submitted QC: 2021-07-15
• Study First Posted: 2021-07-26
• Last Update Submitted: 2021-08-20
• Last Update Posted: 2021-08-26
• Study Start: 2021-09-01
• Primary Completion: 2022-09-01
• Study Completion: 2022-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100000

Inclusion Criteria

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

Exclusion Criteria

• The paediatric and gynaeco-obstetric departments

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
adult (≥ 18 years) inpatients (hospitalised ≥ 48h)	Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer	-

Primary Outcome Measures

Name	Time	Method
Prescription rate of all systemic antibiotics	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 Outcome Measures

Name	Time	Method
All-cause intra-hospital mortality rate	Calculated monthly during a 12-month before and 12-month after period	All causes of death/1 000 inpatients/month
Proportion of the antibiotic prescriptions compliant with guidelines	Calculated monthly during a 12-month before and 12-month after period	Number of antibiotic prescriptions compliant with guidelines/number of antibiotic prescriptions evaluated
Proportion of C. difficile infections	Calculated monthly during a 12-month before and 12-month after period	Number of stays with C. difficile infections/number of stays with antibiotic treatment/month
Proportion of multidrug resistant bacteria identification	Calculated monthly during a 12-month before and 12-month after period	Number of stays with MDRB identification by bacterial sample done after 48h of hospitalization/number of stays with identification of bacterial isolates/month
Users' satisfaction and acceptability	During the 12-month after period	* Satisfaction (qualitative study after 6 months of use); * Proportion of APSS' alerts accepted by the AMS team (number of APSS' alerts accepted by the AMS team/number of alerts generated by APSS/month); * Proportion of AMS team's recommendations accepted by prescribers (number of AMS team's recommendations accepted by prescribers/number of recommendations given by the AMS team to prescribers/month)
Average length of stay	Calculated monthly during a 12-month before and 12-month after period	Total length of stay for each inpatient/number of stays/month
Incidence of healthcare associated infections	Calculated monthly during a 12-month before and 12-month after period	New cases of HCAI/ number of inpatients/month
Proportion of the additional precaution prescriptions compliant with hospital recommendations	Calculated monthly during a 12-month before and 12-month after period	Number of additional precaution prescriptions compliant with hospital recommendations/number of additional precaution prescriptions evaluated
Hospital costs	During the 12-month after period	* Costs of antibiotics (costs (in €) of all oral and intravenous antibiotics delivered by hospital pharmacy/month); * Average cost of hospital stays (costs (in €) of hospital stays for each inpatient/number of stays/month); * Costs of the implementation of the CDSS/ESS and of the purchased equipment (costs (in €) of installation and maintenance of the CDSS/ESS after 12 months of implementation)
Use of overall antibiotics and by therapeutic classes	Calculated monthly during a 12-month before and 12-month after period	DDDs/1 000 patients/month