New Care Pathway for Bloodstream Infection

Recruiting at 100 trial locations

Overseen By Justin Chen, MD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: University of Alberta

Disqualifiers: Imminent death, C-level GCD, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

1800 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications.

What data supports the effectiveness of the treatment for the new care pathway for bloodstream infection?

Research shows that structured interventions, like those involving clinical pharmacists and infectious disease specialists, improve the management of Staphylococcus aureus bacteremia (SAB) by ensuring timely and appropriate antibiotic use, which can lead to better patient outcomes and increased survival rates. ^{1 2 3 4 5}

Is the new care pathway for bloodstream infection safe for humans?

The studies reviewed focus on improving treatment outcomes for Staphylococcus aureus bloodstream infections, but they do not provide specific safety data for the care pathway itself. They emphasize the role of structured interventions and antibiotic management in improving patient outcomes. ^{1 2 6 7 8}

How is the OPTIMUS-SAB treatment for bloodstream infection different from other treatments?

The OPTIMUS-SAB treatment is unique because it involves a structured care pathway led by clinical pharmacists and infectious diseases physicians, focusing on timely and targeted antibiotic therapy, repeat blood cultures, and appropriate therapy duration, which are not standard in all treatments. ^{1 2 8 9 10}

What is the purpose of this trial?

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.

Research Team

Justin Chen, MD

Principal Investigator

University of Alberta

Eligibility Criteria

This trial is for adults over 18 in Alberta, Canada, who have been admitted to a hospital with a confirmed blood infection caused by Staphylococcus aureus. It's designed to help those particularly at high risk of complications from this type of infection.

Inclusion Criteria

My blood test in Alberta confirmed I have a S. aureus infection.

I am currently admitted to an acute care facility in Alberta, Canada.

I am over 18 years old.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Implementation

Implementation of the OPTIMUS-SAB model with real-time automated notifications and centralized SAB care team interventions

3 years

Continuous monitoring and intervention

Follow-up

Participants are monitored for adherence to quality-of-care indicators and outcomes such as length of stay, mortality, and readmission rates

180 days

Treatment Details

Interventions

• OPTIMUS-SAB clinical care pathway

Trial Overview The OPTIMUS-SAB clinical care pathway is being tested. This involves a specialized team that gets notified about positive S. aureus blood tests and then recommends treatment based on best practices to improve patient outcomes across Alberta.

Participant Groups

Group I: OPTIMUS-SAB care pathway Experimental Treatment 1 Intervention

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).

Group II: Standard of care Active Control 1 Intervention

OPTIMUS-SAB clinical care pathway is already approved in Canada for the following indications:

Approved in Canada as OPTIMUS-SAB for:

• Management of Staphylococcus aureus bacteremia

Who Is Running the Clinical Trial?

University of Alberta

Lead Sponsor

Trials

957

Recruited

437,000+

Alberta Health services

Collaborator

Trials

168

Recruited

658,000+

Findings from Research

A pharmacist-led intervention for managing Staphylococcus aureus bacteremia (SAB) significantly improved adherence to optimal care metrics, including timely antibiotic therapy and appropriate treatment duration, as evidenced by a higher percentage of patients achieving a perfect optimal care score (OCS).

The intervention also resulted in lower rates of patient readmission and mortality, highlighting its effectiveness in enhancing patient outcomes in SAB management.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of a pharmacist-driven care package on Staphylococcus aureus bacteremia management in a large community healthcare network: A propensity score-matched, quasi-experimental study. Smith, JR., Frens, JJ., Snider, CB., et al.[2018]

In a study of 271 adult patients with Staphylococcus aureus bacteraemia (SAB), implementing a structured intervention bundle significantly reduced mortality rates, with 14-day mortality dropping from 18% to 2% and 30-day mortality from 20% to 5% when comparing standard care to the intervention.

High compliance (over 75%) with the intervention bundle was associated with lower mortality, highlighting the importance of standardized care in improving patient outcomes, while the intervention required only about 50 minutes of time per patient.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Moving beyond unsolicited consultation: additional impact of a structured intervention on mortality in Staphylococcus aureus bacteraemia. Pérez-Rodríguez, MT., Sousa, A., López-Cortés, LE., et al.[2020]

The implementation of a standardized management bundle for Staphylococcus aureus bacteremia (SAB) through unsolicited prospective audit and feedback significantly improved adherence to evidence-based practices, with infectious diseases consultations increasing from 56.5% to 93.4% and appropriate antibiotic therapy rising from 83.9% to 99.3%.

While the intervention did not significantly reduce readmission or 30-day mortality rates, it demonstrated that a structured approach to managing SAB can enhance treatment consistency and potentially improve patient outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of an Unsolicited, Standardized Form-Based Antimicrobial Stewardship Intervention to Improve Guideline Adherence in the Management of Staphylococcus aureus Bacteremia. Remtulla, S., Zurek, K., Cervera, C., et al.[2022]

In a study of 64 cases of Staphylococcus aureus bacteremia at a community hospital, implementing an antibiotic stewardship bundle significantly increased adherence to treatment protocols from 0.8 to 3.7, which was statistically significant (p < 0.001).

The intervention led to a dramatic reduction in in-hospital mortality from 44% to 10% (p < 0.001), suggesting that improved adherence to care standards can greatly enhance patient outcomes in smaller hospitals.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adherence to an antibiotic stewardship bundle targeting Staphylococcus aureus blood stream infections at a 200-bed community hospital. Borde, JP., Batin, N., Rieg, S., et al.[2022]

The introduction of structured bedside consultation (SBC) at Rijnstate Hospital improved 365-day survival rates for patients with Staphylococcus aureus bacteraemia (SAB) from 56% to 64%, indicating a long-term benefit of this approach.

Patients receiving SBC also had a significant increase in receiving adequate therapy within the first two weeks (from 67.8% to 86.7%) and in complicated cases (from 70.5% to 93.2%), highlighting the effectiveness of SBC in improving treatment outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Increased overall survival after introduction of structured bedside consultation in Staphylococcus aureus bacteraemia. Ariaans, MBPA., Roovers, EA., Claassen, MAA., et al.[2018]

In a retrospective study of low-risk patients with Staphylococcus aureus bacteremia (SAB), a short course of intravenous antibiotics followed by about 10 days of oral antibiotics (mainly beta-lactams) was found to be effective.

The findings suggest that oral stepdown therapy could be a viable option for treating low-risk SAB, but further prospective trials are needed to confirm its efficacy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early Oral Antibiotic Switch for Staphylococcus aureus Bacteremia: Many Are Called, but Few Are Chosen. Holland, TL.[2020]

The implementation of an automated clinical decision support system significantly improved adherence to Staphylococcus aureus bacteraemia management bundles by 27.2%, indicating enhanced compliance with best practices among physicians.

The use of this system also led to a reduction in the composite outcome of 30-day mortality or 90-day readmission due to SAB complications, suggesting potential improvements in patient safety and clinical outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of an automated antibiotic stewardship intervention for the management of Staphylococcus aureus bacteraemia utilizing the electronic health record. Brotherton, AL., Rab, S., Kandiah, S., et al.[2021]

Clinical trials for Staphylococcus aureus bloodstream infections (SAB) are essential for both regulatory approval of new antibiotics and for determining the best treatment strategies using existing antibiotics.

Challenges such as high costs, complexity, and regulatory uncertainties have limited the number of these critical trials, highlighting the need for improved trial design considerations for researchers and sponsors.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults. Holland, TL., Chambers, HF., Boucher, HW., et al.[2022]

Staphylococcus aureus bacteremia (SAB) is a serious bloodstream infection with a 30-day all-cause mortality rate of approximately 20%, highlighting its severity and the need for effective treatment strategies.

Early involvement of Infectious Diseases (ID) specialists and Antimicrobial Stewardship Programs (ASP) can significantly improve outcomes and optimize therapy for patients with SAB.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Staphylococcus aureus Bacteremia: Contemporary Management. Abraham, L., Bamberger, DM.[2021]

In a study of 1851 adult patients with Staphylococcus aureus bloodstream infection across 11 hospitals, 90-day mortality rates varied significantly, ranging from 23% to 39%, indicating differences in quality of care among hospitals.

Factors such as age, type of infection acquisition, and severity of disease were found to be independently associated with mortality, suggesting that crude mortality rates alone are not reliable indicators of hospital quality due to variations in patient demographics.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Survival following Staphylococcus aureus bloodstream infection: A prospective multinational cohort study assessing the impact of place of care. Nambiar, K., Seifert, H., Rieg, S., et al.[2022]

References

1. United States pubmed.ncbi.nlm.nih.gov

Impact of a pharmacist-driven care package on Staphylococcus aureus bacteremia management in a large community healthcare network: A propensity score-matched, quasi-experimental study. [2018]

2. England pubmed.ncbi.nlm.nih.gov

Moving beyond unsolicited consultation: additional impact of a structured intervention on mortality in Staphylococcus aureus bacteraemia. [2020]

3. United States pubmed.ncbi.nlm.nih.gov

Impact of an Unsolicited, Standardized Form-Based Antimicrobial Stewardship Intervention to Improve Guideline Adherence in the Management of Staphylococcus aureus Bacteremia. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

Adherence to an antibiotic stewardship bundle targeting Staphylococcus aureus blood stream infections at a 200-bed community hospital. [2022]

5. Germany pubmed.ncbi.nlm.nih.gov

Increased overall survival after introduction of structured bedside consultation in Staphylococcus aureus bacteraemia. [2018]

6. United States pubmed.ncbi.nlm.nih.gov

Early Oral Antibiotic Switch for Staphylococcus aureus Bacteremia: Many Are Called, but Few Are Chosen. [2020]

7. England pubmed.ncbi.nlm.nih.gov

The impact of an automated antibiotic stewardship intervention for the management of Staphylococcus aureus bacteraemia utilizing the electronic health record. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Considerations for Clinical Trials of Staphylococcus aureus Bloodstream Infection in Adults. [2022]

9. United States pubmed.ncbi.nlm.nih.gov

Staphylococcus aureus Bacteremia: Contemporary Management. [2021]

10. England pubmed.ncbi.nlm.nih.gov

Survival following Staphylococcus aureus bloodstream infection: A prospective multinational cohort study assessing the impact of place of care. [2022]