1440 Participants Needed

Decision Support for Antibiotic Selection in Sepsis

(IDEAS-CRXO Trial)

Recruiting at 2 trial locations
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Ottawa Hospital Research Institute
Must be taking: Antibiotics
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

As antibiotic resistance increases globally, it becomes more difficult to select empiric antibiotic therapy, particularly in patients with sepsis who stand to benefit from early adequate treatment. In particular it is difficult for clinicians to balance antibiotic stewardship principles (the need to avoid unnecessary prescribing of antibiotics that have an excessively broad spectrum of activity that favour resistance development) and under treatment. The integration of multiple risk variables for resistance are hard for clinicians to translate into clinical action, and is seemingly at odds with the natural inclination to provide heuristic/emotion-based antibiotic selection. The inappropriate treatment of sepsis is not uniformly too broad, or too narrow, and there is a need to optimize and tailor selection of antibiotic therapy to each patient, such that those that are at risk for resistant organisms receive broad therapy, and those that are not at risk, receive narrower antibiotic agents.Clinicians need support picking the right antibiotic for each patient, and from this they can potentially drive reduction of unnecessarily broad antibiotic prescribing while preserving adequacy of treatment. Individualized clinical prediction models and decision support interventions are promising approaches that meet these needs by improving the classification of patient risk for antibiotic resistant or susceptible infections in sepsis. Unfortunately, few have been validated in the clinical setting and larger rigorous studies are needed to provide the evidence to support broader clinical adoption.The investigators will perform a cluster randomized cross-over trial of an individualized antibiotic prescribing decision support intervention for providers treating hospitalized patients with suspected sepsis. The aim of this trial is to determine whether a stewardship led clinical decision support intervention can improve antibiotic de-escalation in patients with sepsis while maintaining or improving adequacy of antibiotic coverage. This decision support intervention will be based on a combination of proven decision heuristics (for Gram-positive organisms) and modelled predicted susceptibilities (for Gram-negative organisms) that are individualized to the patient. The primary outcome will be the proportion of patients de-escalated from their initial empiric regimen at 48 hours.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications. However, it focuses on patients who have just started certain antibiotics, so it might be best to discuss your specific situation with the trial coordinators.

Is the clinical decision support system for antibiotic selection in sepsis safe for humans?

The clinical decision support system for antibiotic selection aims to reduce the risk of adverse drug events by providing physicians with a sorted list of antibiotics based on toxicity risk. Evaluations of similar systems suggest they can be useful and generally safe, though user experiences may vary.12345

How is the treatment Integrated Clinical Decision Support (Merrem IV) different from other treatments for sepsis?

Integrated Clinical Decision Support (Merrem IV) is unique because it combines a decision support tool with antibiotic therapy, helping doctors choose the right antibiotic and dosage for sepsis patients. This approach aims to improve treatment accuracy and reduce unnecessary antibiotic use, which can help prevent antibiotic resistance.678910

What data supports the effectiveness of the treatment Integrated Clinical Decision Support, Merrem IV for sepsis?

Research shows that computerized decision support systems can improve antibiotic treatment by reducing unnecessary use and improving appropriate prescribing, which can help in managing sepsis effectively.678911

Who Is on the Research Team?

DR

Derek R Principal Investigator

Principal Investigator

The Ottawa Hospital Research Institute

Are You a Good Fit for This Trial?

This trial is for hospitalized adults over 18 years old with suspected sepsis who have had blood cultures ordered within 12 hours before or after starting antibiotics. It's not suitable for those allergic to the listed antibiotics like Vancomycin, Linezolid, and others.

Inclusion Criteria

I am currently admitted to a hospital.
My blood was tested for infection before or after starting antibiotics.
I am not allergic to common antibiotics like Vancomycin, Ciprofloxacin, or Gentamicin.
See 1 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Treatment

Implementation of a clinical decision support intervention for empiric antibiotic selection in sepsis

48 hours
Continuous monitoring during hospital stay

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessment of antibiotic de-escalation and other outcomes

90 days
Regular assessments during hospital stay and follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Integrated Clinical Decision Support
Trial Overview The study tests a clinical decision support algorithm designed to help doctors choose the right empiric antibiotic therapy for sepsis patients. The goal is to balance treatment effectiveness with antibiotic stewardship to prevent resistance.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Clinical Decision Support Algorithm for Empiric Antibiotics in SepsisExperimental Treatment1 Intervention
The planned intervention consists of a pharmacist-facilitated clinical decision support intervention, where pharmacists provide options and recommendations on empiric sepsis antibiotic selection to hospital providers.
Group II: Standard of CareActive Control1 Intervention
Non-intervention group. No decision support is provided. Patient care is routine.

Integrated Clinical Decision Support is already approved in United States, European Union, Canada for the following indications:

🇺🇸
Approved in United States as Merrem IV for:
  • Complicated skin and skin structure infections
  • Intra-abdominal infections
  • Bacterial meningitis
🇪🇺
Approved in European Union as Meropenem for:
  • Severe pneumonia
  • Urinary tract infections
  • Complicated skin and soft tissue infections
  • Intra-abdominal infections
  • Gynaecological infections
  • Septicaemia
  • Bacterial meningitis
🇨🇦
Approved in Canada as Meropenem for:
  • Complicated skin and skin structure infections
  • Intra-abdominal infections
  • Bacterial meningitis

Find a Clinic Near You

Who Is Running the Clinical Trial?

Ottawa Hospital Research Institute

Lead Sponsor

Trials
585
Recruited
3,283,000+

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials
1,417
Recruited
26,550,000+

Published Research Related to This Trial

The TREAT decision support system significantly improved the rate of appropriate antibiotic treatment in patients with suspected bacterial infections, achieving 70% compliance compared to 57% by physicians, while also using less broad-spectrum antibiotics and reducing costs by half.
In a randomized trial involving 2326 patients, intervention wards using TREAT had a higher rate of appropriate treatment (73% vs. 64%) and showed significant reductions in hospital stay length and total antibiotic costs, highlighting its efficacy in optimizing antibiotic use and minimizing resistance.
Improving empirical antibiotic treatment using TREAT, a computerized decision support system: cluster randomized trial.Paul, M., Andreassen, S., Tacconelli, E., et al.[2022]
The implementation of a computerized decision support tool in an ICU led to a significant reduction in the use of broad-spectrum antibiotics, including carbapenems and third-generation cephalosporins, indicating improved antibiotic stewardship.
The tool also resulted in fewer mismatches between antibiotic susceptibility and initial therapy, promoting the use of narrower spectrum antibiotics and enhancing the overall effectiveness of antibiotic prescribing practices.
Reduction of broad-spectrum antibiotic use with computerized decision support in an intensive care unit.Thursky, KA., Buising, KL., Bak, N., et al.[2016]
Current mortality prediction models (MPMs) for sepsis do not adequately address patients classified as 'good,' highlighting a gap in tools available for clinicians to assess risk in this group.
Machine learning techniques using minimal medical records show promise in developing more efficient and user-friendly MPMs, which could enhance clinical decision-making and improve patient outcomes in sepsis management.
Prognostic tools for elderly patients with sepsis: in search of new predictive models.Gamboa-Antiñolo, FM.[2021]

Citations

Improving empirical antibiotic treatment using TREAT, a computerized decision support system: cluster randomized trial. [2022]
Reduction of broad-spectrum antibiotic use with computerized decision support in an intensive care unit. [2016]
Prognostic tools for elderly patients with sepsis: in search of new predictive models. [2021]
A two-stage clinical decision support system for early recognition and stratification of patients with sepsis: an observational cohort study. [2020]
The development and implementation of a guideline-based clinical decision support system to improve empirical antibiotic prescribing. [2022]
Reducing the Toxicity Risk in Antibiotic Prescriptions by Combining Ontologies with a Multiple Criteria Decision Model. [2023]
Evaluation of a computer-assisted antibiotic-dose monitor. [2017]
End-user evaluation of an interface for clinical decision support using predictive algorithms. [2022]
User interface approaches implemented with automated patient deterioration surveillance tools: protocol for a scoping review. [2022]
10.United Statespubmed.ncbi.nlm.nih.gov
A computer-assisted management program for antibiotics and other antiinfective agents. [2022]
11.United Statespubmed.ncbi.nlm.nih.gov
A decision support tool for antibiotic therapy. [2018]
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