Actively Recruiting
Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis
Led by Ottawa Hospital Research Institute · Updated on 2025-03-17
1440
Participants Needed
3
Research Sites
71 weeks
Total Duration
On this page
Sponsors
O
Ottawa Hospital Research Institute
Lead Sponsor
C
Canadian Institutes of Health Research (CIHR)
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Admitted to hospital
- Age greater than 18 years old
- Newly started (within 24 hours) on at least one specified antibiotic: Vancomycin IV, Linezolid, Daptomycin, Clindamycin, Cefazolin, Cloxacillin, Ceftriaxone, Ceftazidime, Piperacillin-Tazobactam, Meropenem (or Imipenem or Ertapenem), Ciprofloxacin
- Blood cultures ordered within 12 hours before or after starting antibiotics
You will not qualify if you...
- Pregnancy or breastfeeding
- Receiving documented end-of-life (palliative) care and not continuing antibiotic treatment
- Already enrolled in this trial
- Positive clinical culture results with speciation available within 72 hours before assessment; blood cultures positive for Gram-positive bacteria are excluded
- Underwent explanatory molecular testing (e.g., legionella urinary antigen, SARS-CoV-2) within 72 hours before assessment
- Received antimicrobials (not for chronic suppression or prophylaxis) in the prior 24-72 hours unless started outpatient or in emergency before admission
- Antibiotic prescription is a continuation of suppressive chronic therapy or long-standing infection treatment
- Antibiotics given only peri-operatively or for less than 24 hours
- Diagnosis of cystic fibrosis
- Currently enrolled in another trial that dictates antimicrobial selection
- Not eligible for any of the decision support algorithms used in the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Trillium Health Partners
Mississauga, Ontario, Canada
Actively Recruiting
2
The Ottawa Hospital
Ottawa, Ontario, Canada
Actively Recruiting
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here