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

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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Healthcare Associated Infection; Antibiotic
• Intervention / Treatment: Device: Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer

• Study Type: Observational
• Enrollment (Anticipated): 100000

Contacts and Locations

• Study Contact: Name: Arnaud Florentin, Dr; Phone Number: +33383155293; Email: a.florentin@chu-nancy.fr
• Study Contact Backup: Name: Alexandre Baudet, Dr; Email: alexandre.baudet@univ-lorraine.fr

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• The paediatric and gynaeco-obstetric departments

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
adult (≥ 18 years) inpatients (hospitalised ≥ 48h)	Device: Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer; Implementation - in our tertiary care university hospital - of a computerized-decision support system (CDSS) facilitating antibiotic stewardship and of an electronic surveillance software (ESS) facilitating infection prevention and control activities

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Prescription rate of all systemic antibiotics	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.	Calculated monthly during a 12-month before and 12-month after period

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-cause intra-hospital mortality rate	All causes of death/1 000 inpatients/month	Calculated monthly during a 12-month before and 12-month after period
Average length of stay	Total length of stay for each inpatient/number of stays/month	Calculated monthly during a 12-month before and 12-month after period
Incidence of healthcare associated infections	New cases of HCAI/ number of inpatients/month	Calculated monthly during a 12-month before and 12-month after period
Use of overall antibiotics and by therapeutic classes	DDDs/1 000 patients/month	Calculated monthly during a 12-month before and 12-month after period
Proportion of the antibiotic prescriptions compliant with guidelines	Number of antibiotic prescriptions compliant with guidelines/number of antibiotic prescriptions evaluated	Calculated monthly during a 12-month before and 12-month after period
Proportion of the additional precaution prescriptions compliant with hospital recommendations	Number of additional precaution prescriptions compliant with hospital recommendations/number of additional precaution prescriptions evaluated	Calculated monthly during a 12-month before and 12-month after period
Proportion of C. difficile infections	Number of stays with C. difficile infections/number of stays with antibiotic treatment/month	Calculated monthly during a 12-month before and 12-month after period
Proportion of multidrug resistant bacteria identification	Number of stays with MDRB identification by bacterial sample done after 48h of hospitalization/number of stays with identification of bacterial isolates/month	Calculated monthly during a 12-month before and 12-month after period
Hospital costs	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)	During the 12-month after period
Users' satisfaction and acceptability	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)	During the 12-month after period

Collaborators and Investigators

• Sponsor: Central Hospital, Nancy, France
• Investigators: Principal Investigator: Arnaud Florentin, Dr, Université de Lorraine, CHRU-Nancy, APEMAC EA4360, F-54000 Nancy, France

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2021
• Primary Completion (ANTICIPATED): September 1, 2022
• Study Completion (ANTICIPATED): September 1, 2022

Study Registration Dates

• First Submitted: July 15, 2021
• First Submitted That Met QC Criteria: July 15, 2021
• First Posted (ACTUAL): July 26, 2021

Study Record Updates

• Last Update Posted (ACTUAL): August 26, 2021
• Last Update Submitted That Met QC Criteria: August 20, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Keywords: Antibiotic resistance; Clinical decision support; Antibiotic stewardship; Healthcare associated infection; Interrupted time series; Infection prevention and control
• Additional Relevant MeSH Terms: Pathologic Processes; Disease Attributes; Iatrogenic Disease; Infections; Communicable Diseases; Cross Infection; Anti-Infective Agents; Anti-Bacterial Agents
• Other Study ID Numbers: 2021PI072

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No