Decision Support for Antibiotic Selection in Sepsis
(IDEAS-CRXO Trial)
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?
Who Is on the Research Team?
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
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Implementation of a clinical decision support intervention for empiric antibiotic selection in sepsis
Follow-up
Participants are monitored for safety and effectiveness after treatment, including assessment of antibiotic de-escalation and other outcomes
What Are the Treatments Tested in This Trial?
Interventions
- Integrated Clinical Decision Support
Integrated Clinical Decision Support is already approved in United States, European Union, Canada for the following indications:
- Complicated skin and skin structure infections
- Intra-abdominal infections
- Bacterial meningitis
- Severe pneumonia
- Urinary tract infections
- Complicated skin and soft tissue infections
- Intra-abdominal infections
- Gynaecological infections
- Septicaemia
- Bacterial meningitis
- 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
Canadian Institutes of Health Research (CIHR)
Collaborator