Staph Aureus BacteremiaNCT06338176
Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB)
A study testing OPTIMUS-SAB clinical care pathway in people with Staph Aureus Bacteremia, run by University of Alberta at 101 sites in Canada.
Trial summary
Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Staph Aureus Bacteremia
- What is being tested?
- OPTIMUS-SAB clinical care pathway
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,542 participants
- Where
- 101 sitesCanada
- Study dates
- 1 May 2024to 30 Apr 2026
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age greater than 18 years at the time of hospital admission
- Confirmed S. aureus bacteremia by blood culture performed at a laboratory in Alberta, Canada
- Admitted to a designated acute care site in Alberta, Canada
Who cannot join
- The treating team believes death is imminent or inevitable .
- GCD are C-level within 48 hours of admission.
- The patient is transferred in from an out-of-province acute care center with a pre-existing SAB diagnosis.
Trial locations and contacts
101 sites in 1 country.
101 sites in 1 country
Canada101 sites
Athabasca Healthcare Centre
Athabasca, Alberta
Mineral Springs Hospital
Banff, Alberta
Barrhead Healthcare Centre
Barrhead, Alberta
Bassano Health Centre
Bassano, Alberta
Beaverlodge Municipal Hospital
Beaverlodge, Alberta
Oilfields General Hospital
Black Diamond, Alberta
Bonnyville Healthcare Centre
Bonnyville, Alberta
Bow Island Health Centre
Bow Island, Alberta
Boyle Healthcare Centre
Boyle, Alberta
Brooks Health Centre
Brooks, Alberta
Arthur J.E. Child Comprehensive Cancer Centre
Calgary, Alberta
Foothills Medical Centre
Calgary, Alberta
Peter Lougheed Centre
Calgary, Alberta
South Health Campus
Calgary, Alberta
Tom Baker Cancer Centre
Calgary, Alberta
St. Mary's Hospital
Camrose, Alberta
Canmore General Hospital
Canmore, Alberta
Cardston Health Centre
Cardston, Alberta
Our Lady of the Rosary Hospital
Castor, Alberta
Claresholm General Hospital
Claresholm, Alberta
Coaldale Health Centre
Coaldale, Alberta
Cold Lake Healthcare Centre
Cold Lake, Alberta
Consort Hospital and Care Centre
Consort, Alberta
Coronation Hospital and Care Centre
Coronation, Alberta
Crowsnest Pass Health Centre
Crowsnest Pass, Alberta
Daysland Health Centre
Daysland, Alberta
Devon General Hospital
Devon, Alberta
Didsbury District Health Services
Didsbury, Alberta
Drayton Valley Hospital and Care Centre
Drayton Valley, Alberta
Drumheller Health Centre
Drumheller, Alberta
Cross Cancer Institute
Edmonton, Alberta
Glenrose Rehabilitation Hospital
Edmonton, Alberta
Grey Nuns Community Hospital
Edmonton, Alberta
Misericordia Community Hospital
Edmonton, Alberta
Royal Alexandra Hospital
Edmonton, Alberta
University of Alberta Hospital
Edmonton, Alberta
Edson Healthcare Centre
Edson, Alberta
Elk Point Healthcare Centre
Elk Point, Alberta
Fairview Health Complex
Fairview, Alberta
Northern Lights Regional Health Centre
Fort McMurray, Alberta
St. Theresa General Hospital
Fort Vermilion, Alberta
Fox Creek Healthcare Centre
Fox Creek, Alberta
Fort Saskatchewan Community Hospital
Ft Saskatchewan, Alberta
Grande Cache Community Health Complex
Grande Cache, Alberta
Grande Prairie Regional Hospital
Grande Prairie, Alberta
Grimshaw / Berwyn and District Community Health Centre
Grimshaw, Alberta
Hanna Health Centre
Hanna, Alberta
Hardisty Health Centre
Hardisty, Alberta
Northwest Health Centre
High Level, Alberta
High Prairie Health Complex
High Prairie, Alberta
High River General Hospital
High River, Alberta
Hinton Healthcare Centre
Hinton, Alberta
Innisfail Health Centre
Innisfail, Alberta
Seton - Jasper Healthcare Centre
Jasper, Alberta
Killam Health Centre
Killam, Alberta
William J Cadzow - Lac La Biche Health Care Centre
Lac La Biche, Alberta
Lacombe Hospital
Lacombe, Alberta
Lamont Health Centre
Lamont, Alberta
Leduc Community Hospital
Leduc, Alberta
Chinook Regional Hospital
Lethbridge, Alberta
Lloydminster Hospital
Lloydminster, Alberta
Manning Community Health Centre
Manning, Alberta
Mayerthorpe Healthcare Centre
Mayerthorpe, Alberta
Sacred Heart Community Healt
McLennan, Alberta
Medicine Hat Regional Hospital
Medicine Hat, Alberta
Olds Hospital and Care Centre
Olds, Alberta
Big Country Hospital
Oyen, Alberta
Peace River Community Health Centre
Peace River, Alberta
Pincher Creek Health Centre
Pincher Creek, Alberta
Ponoka Hospital
Ponoka, Alberta
Provost Health Centre
Provost, Alberta
Raymond Health Centre
Raymond, Alberta
Red Deer Regional Hospital Centre
Red Deer, Alberta
Redwater Health Centre
Redwater, Alberta
Rimbey Hospital
Rimbey, Alberta
Rocky Mountain House Health Centre
Rocky Mountain House, Alberta
Rockyview General Hospital
Rockyview, Alberta
Slave Lake Healthcare Centre
Slave Lake, Alberta
George McDougall - Smoky Lake Healthcare Centre
Smoky Lake, Alberta
Central Peace Health Complex
Spirit River, Alberta
Sturgeon Community Hospital
St. Albert, Alberta
St. Therese - St. Paul Healthcare Centre
St. Paul, Alberta
Stettler Hospital
Stettler, Alberta
Strathmore District Health Services
Strathmore, Alberta
Myron Thompson Health Centre
Sundre, Alberta
Swan Hills Healthcare Centre
Swan Hills, Alberta
Taber Health Centre
Taber, Alberta
Three Hills Health Centre
Three Hills, Alberta
Tofield Health Centre
Tofield, Alberta
Two Hills Health Centre
Two Hills, Alberta
Valleyview Health Centre
Valleyview, Alberta
St. Joseph's General Hospital
Vegreville, Alberta
Vermilion Health Centre
Vermilion, Alberta
Viking Health Centre
Viking, Alberta
Vulcan Community Health Centre
Vulcan, Alberta
Wabasca/Desmarais Healthcare Centre
Wabasca, Alberta
Wainwright Health Centre
Wainwright, Alberta
Westlock Healthcare Centre
Westlock, Alberta
Westview Health Centre
Westview Village, Alberta
Wetaskiwin Hospital
Wetaskiwin, Alberta
Whitecourt Healthcare Centre
Whitecourt, Alberta
About this study
Official title: Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB): A Stepped Wedge Clinical Trial Evaluating the Effectiveness of a Centralized S. Aureus Management Model
Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.
Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.
The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system.
- Conditions
- Staph Aureus Bacteremia
- Being tested
- OPTIMUS-SAB clinical care pathway
- Keywords
- care pathway, infectious disease consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
OPTIMUS-SAB clinical care pathwayOther
Activation of SAB clinical care pathway within EMR system.
| Study group | Role | What they receive |
|---|---|---|
| OPTIMUS-SAB care pathway | Experimental | Province-wide real time automated notifications of new SAB cases will be established and delivered to a centralized SAB care team electronically through Connect Care. The centralized SAB care team consists of a SAB clinical coordinator, ID specialists and other ad hoc representation depending on patient needs. Following patient chart review, the centralized SAB care team contacts the most responsible physician (MRP) to provide preliminary recommendations to optimize care, both verbally and in written format, facilitated by Connect Care (Alberta Health Services electronic medical record). Receives: Other: OPTIMUS-SAB clinical care pathway |
| Standard of care | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adherence to quality-of-care indicators
Defined as:
- ID involvement and time to ID involvement, defined by the presence of an ID consult note and/or recommendations in the chart.
- Repeat blood cultures, to document clearance of bacteremia, within 72 hours from the last positive blood culture.
- Guideline-concordant empiric antibiotic administered and time to receipt.
- Guideline concordant definitive antibiotic administered and time to receipt.
- Therapeutic drug monitoring of patents treatments with vancomycin.
- Appropriate dose adjustment of antimicrobials based on renal function according to local guidelines.
- Echocardiogram (transthoracic or transesophageal) performed within 72 hours of diagnosis.
- Source control achieved.
- Appropriate duration of antibiotic therapy ordered and delivered.
Measured: Within 90 days
Secondary outcomes (6)
Length of stay
Acute hospital length of stay
Measured: 180 days maximum
Hospital re-admission rates
re-admission to acute care rate
Measured: 90 days
All-cause mortality
death from any cause
Measured: 180 days
In hospital mortality
death within hospital stay
Measured: 90 days
Costing evaluation
Cost of SAB treatment related to hospitalization, including physician provision of care, and antibiotics.
Measured: One year
Implementation evaluation
User experience and feedback from patients and providers will be collected at the start and end of each active implementation phase. This information will be paired with assessments of barriers, facilitators, and contextual factors informed by the Consolidated Framework for Implementation Research (CFIR) and Normalization Process Theory during the pre-implementation phase and at the end of active implementation.
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2024
- Study start1 May 2024
- Primary completion31 Oct 2025
- Study completion30 Apr 2026
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 Staph Aureus BacteremiaStudies of the same condition, open and under way.
- More trials run by University of AlbertaThe 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
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 2,542 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alberta
- Sponsor type
- University, hospital or other
- Collaborators
- Alberta Health services
- Responsible party
- Sponsor
- Investigators
- Justin Chen, MD, Principal investigator, University of Alberta
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06338176
- Sponsor's protocol ID
- Pro00128904
- Status last verified
- May 2026
- First submitted
- 23 Mar 2024
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Remtulla S, Zurek K, Cervera C, Hernandez C, Lee MC, Hoang HL. Impact of an Unsolicited, Standardized Form-Based Antimicrobial Stewardship Intervention to Improve Guideline Adherence in the Management of Staphylococcus aureus Bacteremia. Open Forum Infect Dis. 2019 Feb 26;6(4):ofz098. doi: 10.1093/ofid/ofz098. eCollection 2019 Apr.
PubMed 30949538
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing the Management of Staphylococcus Aureus Bacteremia (OPTIMUS-SAB): A Stepped Wedge Clinical Trial Evaluating the Effectiveness of a Centralized S. Aureus Management Model
- ClinicalTrials.gov ID
- NCT06338176
- Acronym / sponsor ID
- Pro00128904
- Conditions
- Staph Aureus Bacteremia
- Keywords
- care pathway, infectious disease consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 2,542 participants (actual)
- Lead sponsor
- University of AlbertaUniversity, hospital or other
- Collaborators
- Alberta Health services
- Study start
- 1 May 2024 (actual)
- Primary completion
- 31 Oct 2025 (actual)
- Study completion
- 30 Apr 2026 (actual)
- First posted
- 29 Mar 2024 (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.
Staphylococcus aureus bacteremia (SAB) is associated with high morbidity and mortality rates with an incidence disproportionately higher in vulnerable populations. Management according to evidence-based care parameters, in particular Infectious Diseases (ID) consultation, is associated with improved mortality. SAB management is suboptimal in Alberta compared to other jurisdictions. An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence to all evidence-based quality-of-care indicators.
Leveraging this pilot work, the investigators aim to implement OPTIMUS-SAB, an enhanced model of the pilot, to optimize and standardize SAB management across Alberta. The implementation study will be a zone-based acute care site stepped wedge design. OPTIMUS-SAB will consist of a centralized SAB care team whom will receive automated notification of all blood cultures positive for S. aureus allowing them to review the patient's medical chart and make preliminary management recommendations according to an evidence-based care bundle.
The investigators will evaluate adherence to evidence-based SAB quality-of-care indicators before and after OPTIMUS-SAB implementation and expect this to improve with a resultant reduction in duration of bacteremia, length of stay, readmission rates, and mortality. In turn, this will translate into cost savings for the health care system.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| OPTIMUS-SAB care pathway | Experimental | Other: OPTIMUS-SAB clinical care pathwayProvince-wide real time automated notifications of new SAB cases will be established and delivered to a centralized SAB care team electronically through Connect Care. The centralized SAB care team consists of a SAB clinical coordinator, ID specialists and other ad hoc representation depending on patient needs. Following patient chart review, the centralized SAB care team contacts the most responsible physician (MRP) to provide preliminary recommendations to optimize care, both verbally and in written format, facilitated by Connect Care (Alberta Health Services electronic medical record). |
| Standard of care | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age greater than 18 years at the time of hospital admission
- Confirmed S. aureus bacteremia by blood culture performed at a laboratory in Alberta, Canada
- Admitted to a designated acute care site in Alberta, Canada
Key exclusion criteria (3 listed)
- The treating team believes death is imminent or inevitable .
- GCD are C-level within 48 hours of admission.
- The patient is transferred in from an out-of-province acute care center with a pre-existing SAB diagnosis.
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 |
|---|---|---|
| OPTIMUS-SAB clinical care pathwayActivation of SAB clinical care pathway within EMR system. | Other | OPTIMUS-SAB care pathway |
Primary outcome
Adherence to quality-of-care indicators
Time frame: Within 90 days
Defined as: 1. ID involvement and time to ID involvement, defined by the presence of an ID consult note and/or recommendations in the chart. 2. Repeat blood cultures, to document clearance of bacteremia, within 72 hours from the last positive blood culture. 3. Guideline-concordant empiric antibiotic administered and time to receipt. 4. Guideline concordant definitive antibiotic administered and time to receipt. 5. Therapeutic drug monitoring of patents treatments with vancomycin. 6. Appropriate dose adjustment of antimicrobials based on renal function according to local guidelines. 7. Echocardiogram (transthoracic or transesophageal) performed within 72 hours of diagnosis. 8. Source control achieved. 9. Appropriate duration of antibiotic therapy ordered and delivered.
6 secondary outcomes
Length of stay
Time frame: 180 days maximum
Hospital re-admission rates
Time frame: 90 days
All-cause mortality
Time frame: 180 days
In hospital mortality
Time frame: 90 days
Costing evaluation
Time frame: One year
Implementation evaluation
Time frame: 3 years
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 12 May 2026.
- Background: PubMed 30949538Remtulla S, Zurek K, Cervera C, Hernandez C, Lee MC, Hoang HL. Impact of an Unsolicited, Standardized Form-Based Antimicrobial Stewardship Intervention to Improve Guideline Adherence in the Management of Staphylococcus aureus Bacteremia. Open Forum Infect Dis. 2019 Feb 26;6(4):ofz098. doi: 10.1093/ofid/ofz098. eCollection 2019 Apr.
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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.
Justin Chen, MD principal investigator
University of Alberta
101 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing OPTIMUS-SAB clinical care pathway in people with Staph Aureus Bacteremia, run by University of Alberta at 101 sites 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 3 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 12 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 101 sites 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?
Adherence to quality-of-care indicators (time frame: Within 90 days). 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 NCT06338176, 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 12 May 2026.