Status:
RECRUITING
Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis
Lead Sponsor:
Ottawa Hospital Research Institute
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Sepsis
Bacterial Infections
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
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...
Eligibility Criteria
Inclusion
- Inclusion Criteria:
- Admitted
- Age \>18 years old
- Newly started (within 24 hours of assessment for eligibility) on at least one of the following antibiotic(s):
- I. Vancomycin IV II. Linezolid III. Daptomycin IV. Clindamycin V. Cefazolin VI. Cloxacillin VII. Ceftriaxone VIII. Ceftazidime IX. Piperacillin-Tazobactam X. Meropenem (or Imipenem or Ertapenem) XI. Ciprofloxacin
- Blood cultures ordered (within 12 hours before or after initiation of index antibiotics).
- Overall Exclusion:
- Pregnancy/breastfeeding
- Documented end-of-life (palliative) care and are/will not be receiving ongoing antibiotic treatment.
- Already enrolled in the trial.
- Positive clinical culture results (those with speciation) for the index infection (within 72 hours) already available prior to assessment. Blood cultures with any Gram-positives will be an exclusion. Other cultures that are positive with a Gram-stain result but not speciation will not be an exclusion criteria.
- Explanatory molecular test (e.g. legionella urinary antigen test, sars-cov-2 testing) within 72 hours prior to assessment.
- Receipt of antimicrobials (not chronic suppression or prophylaxis) in the prior 24-72 hours (except if started in the outpatient setting or ED prior to admission in the 24-72 hours).
- The index prescription is a continuation of an antibiotic given for suppressive chronic therapy or long-standing treatment of an established infection.
- Index antibiotics are peri-operative only or ordered for \<24 hours.
- Cystic fibrosis.
- Known to be enrolled in a trial that dictates antimicrobial selection.
- Not eligible for any of the algorithms.
Exclusion
Key Trial Info
Start Date :
May 21 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 1 2025
Estimated Enrollment :
1440 Patients enrolled
Trial Details
Trial ID
NCT06103500
Start Date
May 21 2024
End Date
October 1 2025
Last Update
March 17 2025
Active Locations (3)
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1
Trillium Health Partners
Mississauga, Ontario, Canada
2
The Ottawa Hospital
Ottawa, Ontario, Canada
3
Sunnybrook Health Sciences Centre
Toronto, Ontario, Canada