Bacterial InfectionsNCT01587937
Hospital Wide Roll-Out of Antimicrobial Stewardship
A study testing Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics in people with Bacterial Infections, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
Trial summary
Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in hospitals is unnecessary or inappropriate. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Bacterial Infections
- What is being tested?
- Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 19,220 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2010to Apr 2012
- Phase
- Interventional
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- admitted to one of these services: general internal medicine, cardiology, nephrology, orthopedic surgery, neurosurgery, general surgery or trauma surgery
- receiving 3rd or 10th day of treatment with one of the following antibiotics:
- ceftriaxone, ceftazidime, piperacillin-tazobactam, ciprofloxacin, levofloxacin, meropenem, ertapenem, vancomycin
Who cannot join
- patient being followed by the infectious diseases consult service
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial
Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has published guidelines stating that all hospitals should develop an institutional program to enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic stewardship audit-and-feedback intervention for all patients reaching their third or tenth day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The investigators hypothesize that this intervention will result in similar benefits outside of the intensive care unit, and so expanded the intervention to non-ICU medical and surgical wards. To increase the rigor of our program evaluation, the roll-out was conducted in a stepped-wedge randomized controlled design.
- Conditions
- Bacterial Infections
- Being tested
- Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics
- Keywords
- Antibiotic stewardship., Clostridium difficile infection., Antibiotic resistance.
- Medical subject headings
- Bacterial Infections, Clostridium Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibioticsOther
See primary outcome for list of targeted drugs. See citations for previous publications describing the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Antibiotic stewardship intervention | Experimental | Audit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial Receives: Other: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics |
| Control | No intervention | The pre-intervention period will serve as the control period on each medical and surgical service. The cross-over is uni-directional from control to intervention; all services receive the intervention by the end of the study. This is a stepped wedge design. The order of roll-out is randomized. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)
- Targeted broadspectrum antibiotics include third generation cephalosporins (ceftriaxone, ceftazidime), beta-lactam beta-lactamase inhibitors (piperacillin-tazobactam), fluoroquinolones (ciprofloxacin, levofloxacin), carbapenems (ertapenem and meropenem), and glycopeptides (vancomycin)
- DOTs are defined as the number of unique antibiotic agents prescribed each day (regardless of dose)
Measured: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Secondary outcomes (4)
Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs)
-Definition as per primary outcome, but can include any antibiotic (not just those broadspectrum agents targeted by the intervention)
Measured: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Costs of antibiotic therapy ($) per patient day
Based on acquisition costs for each agent.
Measured: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Hospital-acquired Clostridium difficile infection.
Cases of Clostridium difficile infection deemed to have been acquired during the current hospital stay by prospective Infection Prevention \& Control surveillance team.
Measured: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Antibiotic susceptibility of gram negative bacterial isolates
Measured: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Apr 2012 (estimated)
- Study startApr 2010
- Primary completionApr 2012
- Study completionApr 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Bacterial InfectionsStudies of the same condition, open and under way.
- More trials run by Sunnybrook Health Sciences CentreThe 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 19,220 participants (actual)
Sponsor and investigators
- Lead sponsor
- Sunnybrook Health Sciences Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Responsible party
- Sponsor
- Investigators
- Nick Daneman, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01587937
- Sponsor's protocol ID
- 416-2009
- Status last verified
- Nov 2014
- First submitted
- 13 Apr 2012
- Last updated
- 19 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Elligsen M, Walker SA, Simor A, Daneman N. Prospective audit and feedback of antimicrobial stewardship in critical care: program implementation, experience, and challenges. Can J Hosp Pharm. 2012 Jan;65(1):31-6. doi: 10.4212/cjhp.v65i1.1101. No abstract available.
PubMed 22479110Elligsen M, Walker SA, Pinto R, Simor A, Mubareka S, Rachlis A, Allen V, Daneman N. Audit and feedback to reduce broad-spectrum antibiotic use among intensive care unit patients: a controlled interrupted time series analysis. Infect Control Hosp Epidemiol. 2012 Apr;33(4):354-61. doi: 10.1086/664757.
PubMed 22418630
Study at a glance
From the registry record, last updated by the sponsor on 19 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hospital Wide Roll-Out of Antimicrobial Stewardship: A Stepped Wedge Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01587937
- Acronym / sponsor ID
- 416-2009
- Conditions
- Bacterial Infections
- Keywords
- Antibiotic stewardship., Clostridium difficile infection., Antibiotic resistance.
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19,220 participants (actual)
- Lead sponsor
- Sunnybrook Health Sciences CentreUniversity, hospital or other
- Collaborators
- Ontario Ministry of Health and Long Term Care
- Study start
- Apr 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Apr 2012 (actual)
- First posted
- 30 Apr 2012 (estimated)
- 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.
Dramatic increases in antibiotic utilization in hospitals continue to drive antibiotic resistance among hospital-acquired pathogens. However, 30-50% of the antibiotic use in hospitals is unnecessary or inappropriate. The Infectious Diseases Society of America has published guidelines stating that all hospitals should develop an institutional program to enhance antimicrobial stewardship. At Sunnybrook Health Sciences Centre, an antibiotic stewardship audit-and-feedback intervention for all patients reaching their third or tenth day of broadspectrum antibiotic use in intensive care, resulted in a reduction of antibiotic use, antibiotic costs, and Clostridium difficile infections in the intensive care unit. The investigators hypothesize that this intervention will result in similar benefits outside of the intensive care unit, and so expanded the intervention to non-ICU medical and surgical wards. To increase the rigor of our program evaluation, the roll-out was conducted in a stepped-wedge randomized controlled design.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Antibiotic stewardship intervention | Experimental | Other: Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibioticsAudit-and-feedback intervention to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antimicrobial |
| Control | No intervention | –The pre-intervention period will serve as the control period on each medical and surgical service. The cross-over is uni-directional from control to intervention; all services receive the intervention by the end of the study. This is a stepped wedge design. The order of roll-out is randomized. |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- admitted to one of these services: general internal medicine, cardiology, nephrology, orthopedic surgery, neurosurgery, general surgery or trauma surgery
- receiving 3rd or 10th day of treatment with one of the following antibiotics:
- ceftriaxone, ceftazidime, piperacillin-tazobactam, ciprofloxacin, levofloxacin, meropenem, ertapenem, vancomycin
Key exclusion criteria (1 listed)
- patient being followed by the infectious diseases consult service
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 audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibioticsSee primary outcome for list of targeted drugs. See citations for previous publications describing the intervention. | Other | Antibiotic stewardship intervention |
Primary outcome
Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs)
Time frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
* Targeted broadspectrum antibiotics include third generation cephalosporins (ceftriaxone, ceftazidime), beta-lactam beta-lactamase inhibitors (piperacillin-tazobactam), fluoroquinolones (ciprofloxacin, levofloxacin), carbapenems (ertapenem and meropenem), and glycopeptides (vancomycin) * DOTs are defined as the number of unique antibiotic agents prescribed each day (regardless of dose)
4 secondary outcomes
Days of antibiotic therapy of any antibiotic agent(DOTs)per patient days (PDs)
Time frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Costs of antibiotic therapy ($) per patient day
Time frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Hospital-acquired Clostridium difficile infection.
Time frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Antibiotic susceptibility of gram negative bacterial isolates
Time frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2014.
- Background: PubMed 22479110Elligsen M, Walker SA, Simor A, Daneman N. Prospective audit and feedback of antimicrobial stewardship in critical care: program implementation, experience, and challenges. Can J Hosp Pharm. 2012 Jan;65(1):31-6. doi: 10.4212/cjhp.v65i1.1101. No abstract available.
- Background: PubMed 22418630Elligsen M, Walker SA, Pinto R, Simor A, Mubareka S, Rachlis A, Allen V, Daneman N. Audit and feedback to reduce broad-spectrum antibiotic use among intensive care unit patients: a controlled interrupted time series analysis. Infect Control Hosp Epidemiol. 2012 Apr;33(4):354-61. doi: 10.1086/664757.
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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.
Nick Daneman principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Antibiotic stewardship audit-and-feedback to prescribers of patients receiving 3rd or 10th day of targeted broadspectrum antibiotics in people with Bacterial Infections, run by Sunnybrook Health Sciences Centre at 1 site in Canada.
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 3 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: finished, as of the sponsor's last update on 19 Nov 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Days of antibiotic therapy (DOTs) of targeted broadspectrum agents per patient days (PDs) (time frame: patients will be followed until discharge from hospital (expected median 7 days for those on antibiotics)). 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 NCT01587937, which also lists 2 linked publications.
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 19 Nov 2014.