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

NCT04976829 | Unknown

• 1 other identifier: 2021PI072
• Study Type: observational
• Target: 100,000
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Antibiotic; Healthcare Associated Infection

Keywords

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• All-cause intra-hospital mortality rate

  Calculated monthly during a 12-month before and 12-month after period

• Average length of stay

  Calculated monthly during a 12-month before and 12-month after period

• Incidence of healthcare associated infections

  Calculated monthly during a 12-month before and 12-month after period

• Use of overall antibiotics and by therapeutic classes

  Calculated monthly during a 12-month before and 12-month after period

• Proportion of the antibiotic prescriptions compliant with guidelines

  Calculated monthly during a 12-month before and 12-month after period

Study Arms (1)

adult (≥ 18 years) inpatients (hospitalised ≥ 48h)

Device: Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer

Interventions

Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer DEVICE

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

adult (≥ 18 years) inpatients (hospitalised ≥ 48h)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

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

You may not qualify if:

• The paediatric and gynaeco-obstetric departments

Sponsors & Collaborators

• Central Hospital, Nancy, France: lead

Related Publications (1)

• 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.

  PMID: 35383069 DERIVED

MeSH Terms

Conditions

Cross Infection

Condition Hierarchy (Ancestors)

Infections; Iatrogenic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Arnaud Florentin, Dr

  Université de Lorraine, CHRU-Nancy, APEMAC EA4360, F-54000 Nancy, France

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Arnaud Florentin, Dr

CONTACT

+33383155293; a.florentin@chu-nancy.fr

Alexandre Baudet, Dr

CONTACT

alexandre.baudet@univ-lorraine.fr

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 15, 2021
• First Posted: July 26, 2021
• Study Start: September 1, 2021
• Primary Completion: September 1, 2022
• Study Completion: September 1, 2022
• Last Updated: August 26, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share