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Clinical Decision Support Algorithm

Decision Support for Antibiotic Selection in Sepsis (IDEAS-CRXO Trial)

N/A
Recruiting
Research Sponsored by Ottawa Hospital Research Institute
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
I. Vancomycin II. Linezolid III. Daptomycin IV. Cefazolin V. Cloxacillin VI. Ceftriaxone VII. Ceftazidime VIII. Piperacillin-Tazobactam IX. Meropenem (or Imipenem or Ertapenem) X. Ciprofloxacin (or Moxifloxacin or Levofloxacin) XI. Gentamicin (or Tobramycin).
Age >18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Awards & highlights
No Placebo-Only Group

Summary

This trial aims to help clinicians choose the right antibiotics for patients with sepsis, a severe infection. The goal is to balance between giving effective treatment and avoiding unnecessary antibiotics that can lead to resistance.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Since this trial focuses on decision-making rather than new drugs, side effects relate to existing antibiotics used in practice and may include allergic reactions, gastrointestinal issues, kidney damage, or development of resistance.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
I am not allergic to common antibiotics like Vancomycin, Ciprofloxacin, or Gentamicin.
Select...
I am older than 18 years.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Patients De-escalated
Secondary study objectives
Antibiotic spectrum at completion
Days of antibiotic therapy
De-escalation extent
+15 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

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.

Find a Location

Who is running the clinical trial?

Ottawa Hospital Research InstituteLead Sponsor
575 Previous Clinical Trials
3,093,460 Total Patients Enrolled
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,388 Previous Clinical Trials
26,516,633 Total Patients Enrolled
~480 spots leftby Mar 2025