An observational study in Antibiotic and Healthcare Associated Infection, sponsored by Central Hospital, Nancy, France. Status unknown. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2021-08-26.
Sponsored by Central Hospital, Nancy, France · Observational
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.
6,687 studies on the registry are indexed under Infections; 807 are open to participants now.
This study's planned enrollment of 100,000 is above the median of 240 across 2,136 observational studies indexed under Infections.
Browse Infections studies →Central Hospital, Nancy, France is the lead sponsor of 778 studies on the registry; 183 are open to participants now.
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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.
Exclusion Criteria:
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
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.
Time frame: Calculated monthly during a 12-month before and 12-month after period
All-cause intra-hospital mortality rate
All causes of death/1 000 inpatients/month
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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
Time frame: 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)
Time frame: 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)
Time frame: During the 12-month after period
No study locations are listed for this record.
Plan to share: No
This study is status unknown, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.
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Central Hospital, Nancy, France