New Care Pathway for Bloodstream Infection

Recruiting at 102 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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to improve treatment for people with Staphylococcus aureus bacteremia (SAB), a serious blood infection. It introduces the OPTIMUS-SAB clinical care pathway, which involves a team of specialists receiving real-time updates on new SAB cases and providing treatment recommendations. The goal is to improve patient outcomes by reducing infection duration, hospital stays, and readmission rates. Individuals diagnosed with SAB in Alberta and admitted to specific hospitals might be eligible. As an unphased trial, this study offers a unique opportunity to contribute to innovative care strategies that could enhance treatment for future patients.

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 prior data suggests that this care pathway is safe for managing bloodstream infections?

Research has shown that the OPTIMUS-SAB clinical care pathway is under testing to manage Staphylococcus aureus bacteremia, a type of bloodstream infection. This pathway involves a team that receives notifications about new infections and then recommends care steps to doctors.

In previous studies, similar methods have been linked to better care and outcomes. Although this pathway is new, it builds on an earlier study that improved care for these infections. The pathway itself has no specific side effects. Instead, it aims to enhance the treatment process and outcomes for patients with this infection. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the OPTIMUS-SAB care pathway because it introduces a real-time, automated notification system for new bloodstream infection cases, specifically Staphylococcus aureus bacteremia (SAB). Unlike traditional methods that rely on individual healthcare providers to identify and respond to such infections, this pathway uses a centralized team of specialists who promptly advise the most responsible physician on optimizing patient care. This streamlined, tech-enabled approach aims to enhance communication, speed up decision-making, and potentially improve patient outcomes by ensuring timely and coordinated care.

What evidence suggests that the OPTIMUS-SAB care pathway is effective for managing Staphylococcus aureus bacteremia?

Research has shown that the OPTIMUS-SAB care pathway, which participants in this trial may receive, can enhance the treatment of Staphylococcus aureus bacteremia (SAB), a serious bloodstream infection. A pilot study in Alberta found that timely advice, including consultations with infectious disease specialists, led patients to adhere better to care standards. This improved care was linked to lower death rates. The OPTIMUS-SAB model employs a central team that receives real-time alerts about SAB cases to provide immediate care advice. This approach aims to improve patient outcomes by ensuring consistent and effective management of SAB. ^{1 2 4 6 7}

Who Is on the Research Team?

Justin Chen, MD

Principal Investigator

University of Alberta

Are You a Good Fit for This Trial?

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

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

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

I am over 18 years old.

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06338176

Optimizing the Management of Staphylococcus Aureus ... 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 ...

2. withpower.com withpower.com/trial/phase-bacteremia-4-2024-ec9ec

New Care Pathway for Bloodstream Infection A pharmacist-led intervention for managing Staphylococcus aureus bacteremia (SAB) significantly improved adherence to optimal care metrics, including timely ...

3. centerwatch.com centerwatch.com/clinical-trials/listings/NCT06338176/optimizing-the-management-of-staphylococcus-aureus-bacteremia-optimus-sab

Optimizing the Management of Staphylococcus Aureus ... An Alberta-based pilot study confirmed that timely recommendations to optimize SAB care, including ID consultation, was associated with improved adherence.

4. clinconnect.io clinconnect.io/trials/NCT06338176

Optimizing the Management of Staphylococcus Aureus The OPTIMUS-SAB clinical trial is focused on improving the care of patients with Staphylococcus aureus bacteremia (SAB), a serious bloodstream infection.

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11959183/

Contemporary Management of Staphylococcus aureus ... In this review, we seek to provide a comprehensive overview of the evaluation and management of Staphylococcus aureus bacteremia.

6. trial.medpath.com trial.medpath.com/clinical-trial/52de1fe50ca9df8d/nct06338176-optimizing-management-staphylococcus-aureus-bacteremia

Optimizing the Management of Staphylococcus Aureus ... 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 ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC7431060/

Staphylococcus aureus Bacteremia - PubMed Central - NIH Staphylococcus aureus bacteremia (SAB) is a serious cause of bloodstream infection associated with significant morbidity and mortality.