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

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

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04976829
Acronym
MACABAO
Enrollment
100000
Registered
2021-07-26
Start date
2021-09-01
Completion date
2022-09-01
Last updated
2021-08-26

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Antibiotic, Healthcare Associated Infection

Keywords

Antibiotic stewardship, Healthcare associated infection, Clinical decision support, Interrupted time series, Infection prevention and control, Antibiotic resistance

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.

Interventions

DEVICEAntibiotic 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

Sponsors

Central Hospital, Nancy, France
Lead SponsorOTHER

Study design

Observational model
OTHER
Time perspective
OTHER

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

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

Exclusion criteria

* The paediatric and gynaeco-obstetric departments

Design outcomes

Primary

MeasureTime frameDescription
Prescription rate of all systemic antibioticsCalculated monthly during a 12-month before and 12-month after periodThe 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

MeasureTime frameDescription
Average length of stayCalculated monthly during a 12-month before and 12-month after periodTotal length of stay for each inpatient/number of stays/month
Incidence of healthcare associated infectionsCalculated monthly during a 12-month before and 12-month after periodNew cases of HCAI/ number of inpatients/month
Use of overall antibiotics and by therapeutic classesCalculated monthly during a 12-month before and 12-month after periodDDDs/1 000 patients/month
Proportion of the antibiotic prescriptions compliant with guidelinesCalculated monthly during a 12-month before and 12-month after periodNumber of antibiotic prescriptions compliant with guidelines/number of antibiotic prescriptions evaluated
All-cause intra-hospital mortality rateCalculated monthly during a 12-month before and 12-month after periodAll causes of death/1 000 inpatients/month
Proportion of C. difficile infectionsCalculated monthly during a 12-month before and 12-month after periodNumber of stays with C. difficile infections/number of stays with antibiotic treatment/month
Proportion of multidrug resistant bacteria identificationCalculated monthly during a 12-month before and 12-month after periodNumber of stays with MDRB identification by bacterial sample done after 48h of hospitalization/number of stays with identification of bacterial isolates/month
Hospital costsDuring 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)
Users' satisfaction and acceptabilityDuring 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)
Proportion of the additional precaution prescriptions compliant with hospital recommendationsCalculated monthly during a 12-month before and 12-month after periodNumber of additional precaution prescriptions compliant with hospital recommendations/number of additional precaution prescriptions evaluated

Contacts

Primary ContactArnaud Florentin, Dr
a.florentin@chu-nancy.fr+33383155293
Backup ContactAlexandre Baudet, Dr
alexandre.baudet@univ-lorraine.fr

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026