AntibioticMACABAONCT04976829
Evaluating Antibiotic Stewardship Assisted by Computer in the University Hospital of Nancy (MACABAO)
An observational study of Antibiotic and Healthcare Associated Infection, run by Central Hospital, Nancy, France.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Antibiotic, Healthcare Associated Infection
- What is being tested?
- Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer
- Type of treatment
- Medical device
- How many people
- 100,000 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2021to 1 Sep 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- All inpatients ≥ 18 years and hospitalised ≥ 48h in Nancy University Hospital
Who cannot join
- The paediatric and gynaeco-obstetric departments
Trial locations and contacts
No sites are listed yet.
Alexandre Baudet, Dr contact
About this study
Official title: 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.
- Conditions
- Antibiotic, Healthcare Associated Infection
- Being tested
- Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer
- Keywords
- Antibiotic stewardship, Healthcare associated infection, Clinical decision support, Interrupted time series, Infection prevention and control, Antibiotic resistance
- Medical subject headings
- Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic stewardship and healthcare-associated infections surveillance assisted by computerDevice
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
| Study group | Role | What they receive |
|---|---|---|
| adult (≥ 18 years) inpatients (hospitalised ≥ 48h) | Not described Receives: Device: Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Calculated monthly during a 12-month before and 12-month after period
Secondary outcomes (10)
All-cause intra-hospital mortality rate
All causes of death/1 000 inpatients/month
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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)
Measured: 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)
Measured: During the 12-month after period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start1 Sep 2021 (estimated)
- Primary completion1 Sep 2022 (estimated)
- Study completion1 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for AntibioticStudies of the same condition, open and under way.
- More trials run by Central Hospital, Nancy, FranceThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Other
- Time perspective
- Other
- Enrolment
- 100,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Arnaud Florentin, Dr, Principal investigator, Université de Lorraine, CHRU-Nancy, APEMAC EA4360, F-54000 Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04976829
- Sponsor's protocol ID
- 2021PI072
- Acronym
- MACABAO
- Status last verified
- Jul 2021
- First submitted
- 15 Jul 2021
- Last updated
- 26 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 35383069
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Antibiotic Stewardship and Healthcare-associated Infections Surveillance Assisted by Computer in the University Hospital of Nancy
- ClinicalTrials.gov ID
- NCT04976829
- Acronym / sponsor ID
- MACABAO / 2021PI072
- Conditions
- Antibiotic, Healthcare Associated Infection
- Keywords
- Antibiotic stewardship, Healthcare associated infection, Clinical decision support, Interrupted time series, Infection prevention and control, Antibiotic resistance
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 100,000 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 1 Sep 2021 (estimated)
- Primary completion
- 1 Sep 2022 (estimated)
- Study completion
- 1 Sep 2022 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Other
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| adult (≥ 18 years) inpatients (hospitalised ≥ 48h) | – | Device: Antibiotic stewardship and healthcare-associated infections surveillance assisted by computer |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- All inpatients ≥ 18 years and hospitalised ≥ 48h in Nancy University Hospital
Key exclusion criteria (1 listed)
- The paediatric and gynaeco-obstetric departments
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Antibiotic stewardship and healthcare-associated infections surveillance assisted by computerImplementation - 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 | Device | adult (≥ 18 years) inpatients (hospitalised ≥ 48h) |
Primary outcome
Prescription rate of all systemic antibiotics
Time frame: Calculated monthly during a 12-month before and 12-month after period
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.
10 secondary outcomes
All-cause intra-hospital mortality rate
Time frame: Calculated monthly during a 12-month before and 12-month after period
Average length of stay
Time frame: Calculated monthly during a 12-month before and 12-month after period
Incidence of healthcare associated infections
Time frame: Calculated monthly during a 12-month before and 12-month after period
Use of overall antibiotics and by therapeutic classes
Time frame: Calculated monthly during a 12-month before and 12-month after period
Proportion of the antibiotic prescriptions compliant with guidelines
Time frame: Calculated monthly during a 12-month before and 12-month after period
Proportion of the additional precaution prescriptions compliant with hospital recommendations
Time frame: Calculated monthly during a 12-month before and 12-month after period
Proportion of C. difficile infections
Time frame: Calculated monthly during a 12-month before and 12-month after period
Proportion of multidrug resistant bacteria identification
Time frame: Calculated monthly during a 12-month before and 12-month after period
Hospital costs
Time frame: During the 12-month after period
Users' satisfaction and acceptability
Time frame: During the 12-month after period
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2021.
- Derived from this study: PubMed 35383069Baudet 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.
- Individual participant dataSharing planned: No
Related trials for Antibiotic
Not yet recruiting
Safety Study of Microlyte DualGuard
Wound Closure, Wound Care
Not yet recruiting
Expanded Diagnostic Strategy in Older Adults Hospitalized With Community-Acquired Acute Respiratory Infection
Acute Respiratory Infection
Active, not recruitingPhase 2
Response to Emerging Antimicrobial Resistance With Containment Microbiota Therapy (REACT)
Multi-Drug Resistant Organism Colonization
Not yet recruiting
Is Routine Dental Clearance or Antibiotic Prophylaxis Before Dental Procedures Necessary in Total Joint Arthroplasty?
Elective Primary THA or TKA
Recruiting
Probiotics Versus Antibiotics as an Adjuvant to Non-surgical Periodontal Treatment Among Smokers With Stage II, Grade B Periodontitis
Probiotics, Antibiotics
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alexandre Baudet, Dr contact
Arnaud Florentin, Dr principal investigator
Université de Lorraine, CHRU-Nancy, APEMAC EA4360, F-54000 Nancy, France
Questions about this trial
What is this clinical trial studying?
An observational study of Antibiotic and Healthcare Associated Infection, run by Central Hospital, Nancy, France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Arnaud Florentin, Dr (+33383155293, a.florentin@chu-nancy.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prescription rate of all systemic antibiotics (time frame: Calculated monthly during a 12-month before and 12-month after period). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04976829, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2021.