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

Healthcare Associated Infection Clinical Trial

— MACABAO  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04976829
• Other study ID #: 2021PI072
• Status: Not yet recruiting
• Start date: September 1, 2021
• Est. completion date: September 1, 2022

Study information

• Verified date: July 2021
• Source: Central Hospital, Nancy, France
• Contact: Arnaud Florentin, Dr
• Phone: +33383155293
• Email: a.florentin[@]chu-nancy.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 100000
• Est. completion date: September 1, 2022
• Est. primary completion date: September 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

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

Exclusion Criteria:

• The paediatric and gynaeco-obstetric departments

Related Conditions & MeSH terms

• Antibiotic
• Communicable Diseases
• Cross Infection
• Healthcare Associated Infection
• Infection

Intervention

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

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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