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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.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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

Other trials in Canada

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.

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 groups in NCT06338176
Study groupRoleWhat they receive
OPTIMUS-SAB care pathwayExperimentalProvince-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 careNo interventionNot described

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Adherence to quality-of-care indicators

    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.

    Measured: Within 90 days

Secondary outcomes (6)
  1. Length of stay

    Acute hospital length of stay

    Measured: 180 days maximum

  2. Hospital re-admission rates

    re-admission to acute care rate

    Measured: 90 days

  3. All-cause mortality

    death from any cause

    Measured: 180 days

  4. In hospital mortality

    death within hospital stay

    Measured: 90 days

  5. Costing evaluation

    Cost of SAB treatment related to hospitalization, including physician provision of care, and antibiotics.

    Measured: One year

  6. 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.

  1. First posted29 Mar 2024
  2. Study start1 May 2024
  3. Primary completion31 Oct 2025
  4. Study completion30 Apr 2026

Resources

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)
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

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.

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