Improving antibiotic selection for sepsis treatment

Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis: A Cluster Randomized Cross-Over Trial (IDEAS-CRXO)

This study is testing a new tool to help doctors choose the best antibiotics for patients with sepsis to make sure they get the right treatment while also fighting antibiotic resistance.

Quick facts

• Phase: NA
• Study type: Interventional
• Enrollment: 1440 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: Ottawa Hospital Research Institute (other)
• Locations: 3 sites (Mississauga, Ontario and 2 other locations)
• Trial ID: NCT06103500 on ClinicalTrials.gov

What this trial studies

This study focuses on enhancing the selection of empiric antibiotics for patients with sepsis by utilizing a Clinical Decision Support Algorithm. As antibiotic resistance becomes a growing concern, the study aims to balance the need for effective treatment while adhering to antibiotic stewardship principles. By integrating multiple risk variables for resistance, the algorithm seeks to optimize antibiotic therapy tailored to individual patient needs, ensuring those at risk for resistant organisms receive appropriate broad-spectrum therapy, while others receive narrower agents. The intervention will be implemented in various hospitals to assess its effectiveness in real-world clinical settings.

Who should consider this trial

Good fit: Ideal candidates for this study are adults over 18 years old who have been admitted to the hospital and started on specific antibiotics for sepsis within 24 hours.

Not a fit: Patients who are pregnant, receiving end-of-life care, or have positive culture results for the infection prior to assessment may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could lead to more effective and personalized antibiotic treatment for sepsis patients, potentially improving outcomes and reducing antibiotic resistance.

How similar studies have performed: Other studies have shown promise in using clinical decision support systems for antibiotic selection, indicating potential success for this approach.

Eligibility criteria

Inclusion Criteria:

1. Admitted
2. Age \>18 years old
3. 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
4. Blood cultures ordered (within 12 hours before or after initiation of index antibiotics).

Overall Exclusion:

1. Pregnancy/breastfeeding
2. Documented end-of-life (palliative) care and are/will not be receiving ongoing antibiotic treatment.
3. Already enrolled in the trial.
4. 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.
5. Explanatory molecular test (e.g. legionella urinary antigen test, sars-cov-2 testing) within 72 hours prior to assessment.
6. 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).
7. The index prescription is a continuation of an antibiotic given for suppressive chronic therapy or long-standing treatment of an established infection.
8. Index antibiotics are peri-operative only or ordered for \<24 hours.
9. Cystic fibrosis.
10. Known to be enrolled in a trial that dictates antimicrobial selection.
11. Not eligible for any of the algorithms.

Where this trial is running

Mississauga, Ontario and 2 other locations

• Trillium Health Partners — Mississauga, Ontario, Canada (RECRUITING)
• The Ottawa Hospital — Ottawa, Ontario, Canada (RECRUITING)
• Sunnybrook Health Sciences Centre — Toronto, Ontario, Canada (RECRUITING)

Study contacts

• Principal investigator: Derek R Principal Investigator — Ottawa Hospital Research Institute

Conditions: Sepsis, Bacterial Infections, Community-Acquired Infections, Hospital Infection