SepsisIDEAS-CRXONCT06103500
Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis
A study testing Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis in people with Sepsis and Bacterial Infections, run by Ottawa Hospital Research Institute at 3 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Sepsis, Bacterial Infections, Community-Acquired Infections
- What is being tested?
- Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,478 participants
- Where
- 3 sitesCanada
- Study dates
- 21 May 2024to 28 Nov 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Admitted
- Age >18 years old
- Newly started (within 24 hours of assessment for eligibility) on at least one of the following antibiotic(s):
- 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:
Show all 17Show fewer
- 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.
Who cannot join
None listed.
Trial locations and contacts
3 sites in 1 country.
Canada3 sites
Trillium Health Partners
Mississauga, Ontario
The Ottawa Hospital
Ottawa, Ontario
Sunnybrook Health Sciences Centre
Toronto, Ontario
About this study
Official title: Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis: A Cluster Randomized Cross-Over Trial (IDEAS-CRXO)
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.
- Being tested
- Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis
- Medical subject headings
- Sepsis, Bacterial Infections, Community-Acquired Infections, Cross Infection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clinical Decision Support Algorithm for Empiric Antibiotics in SepsisOther
Also called Decision Support Tool
A clinical decision support algorithm for empiric antibiotic selection in suspected infection.
| Study group | Role | What they receive |
|---|---|---|
| Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis | Experimental | 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. Receives: Other: Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis |
| Standard of Care | No intervention | Non-intervention group. No decision support is provided. Patient care is routine. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of Patients De-escalated
De-escalation from empiric antibiotic regimen at 48 hours (or at time of discharge if earlier) from receipt of index antibiotics [Binary].
Measured: 48 hours
Secondary outcomes (19)
Time to adequate therapy for positive blood cultures
Time to adequate therapy for patients with positive blood cultures (hours from time of first index blood culture collection to first dose of agent(s) active against all pathogen(s) in the peri-index positive blood cultures). [Continuous] [Stratified by ampC organisms]
Measured: 0-7 days
Time to adequate therapy for positive non-screening cultures
Time to adequate therapy for patients with positive non-screening cultures including blood cultures (hours from time of first index blood culture collection to first dose of agent(s) active against all pathogen(s) in the peri-index positive cultures). [Continuous][Stratified by ampC organisms]
Measured: 0-7 days
Number of Patients Receiving Adequate Therapy at 48 hours based on blood cultures
Receipt of adequate antibiotic therapy within 48 hours (or discharge if earlier) from first index blood culture collection for patients with positive blood cultures (active against all pathogens in peri-index positive blood cultures). [Binary]
Measured: 48 hours
Number of Patients Receiving Adequate Therapy at 48 hours based on non-screening cultures
Receipt of adequate antibiotic therapy within 48 hours (or discharge if earlier) from first index blood culture collection for patients with positive non-screening cultures including blood (active against all pathogens in peri-index positive cultures). [Binary]
Measured: 48 hours
Mortality
In-hospital mortality, during index admission, and within 90 days of index event. [Binary]
Measured: 90 days
Length of stay
Hospital length of stay on index admission (days) up to 90 days. [Continuous]
Measured: 0-90 days
De-escalation extent
Extent of antibiotic de-escalation at 48 hours from index or discharge if earlier (ordinal value up or down the de-escalation cascade, + escalation, - for de-escalation). [Integer from -infinity to infinity]
Measured: 48 hours
Antibiotic spectrum at completion
Antibiotic spectrum rank at 7 days from index antibiotics (or discharge if earlier). [Ordinal]
Measured: Completion of therapy, up to 90 days
Number of Patients with C.difficile Infection
Positive stool testing for Clostridioides difficile during index admission, and within 90 days of index. [Binary]
Measured: 90 days
Number of Patients Requiring Dialysis
New requirement for dialysis during index admission, and within 90 days of index. [Binary]
Measured: 90 days
Days of antibiotic therapy
Total antibiotic days of therapy (DOT) during the first 7 days from index antibiotics (or prior to discharge if earlier), including by spectrum-level. [Continuous]
Measured: End of index admission, up to 90 days
Number of Patients with Antibiotic Escalation
Newly started Gram-positive or Gram-negative coverage, or increases in spectrum of antibiotic therapy, as part of the intervention recommendation. [Binary]
Measured: 48 hours
Time to De-escalation
Description: Time to antibiotic de-escalation (hours from receipt of index antibiotics). [Continuous][Stratified by ampC organisms]
Measured: 0-7 days
Number of Patients with Recommended change in Gram-negative coverage
Recommended change in antibiotic therapy by Gram-negative model. [Binary]
Measured: At time of assessment (0 days)
Number of Patients with Accepted change in Gram-negative coverage
Recommended change in antibiotic therapy by Gram-negative model was accepted (acceptance defined as change to some or all of the therapy as recommended within 24 hours of index). [Binary]
Measured: Within 24 hours
Number of Patients with Recommended change in Gram-positive coverage
Recommended change in antibiotic therapy by Gram-positive algorithm. [Binary]
Measured: At time of assessment (0 days)
Number of Patients with Accepted change in Gram-positive coverage
Recommended change in antibiotic therapy by Gram-positive algorithm was accepted and ordered (acceptance defined as change to some or all of the therapy as recommended within 24 hours of index). [Binary]
Measured: Within 24 hours
Number of Patients with Non-recommended escalation at 7 days
Escalation of antibiotic therapy (apart from recommended escalation) within 7 days of receipt of index antibiotics (or prior to discharge if earlier). [Binary]
Measured: 7 days
Number of Patients with ICU admit or mortality
Admitted to ICU on day 7 or not alive at day 7 from receipt of index antibiotics. [Binary]
Measured: 7 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Oct 2023
- Study start21 May 2024
- Primary completion20 Apr 2025
- Study completion28 Nov 2025
Why it stopped: Funding.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SepsisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Cluster Randomized Cross-Over Trial
- Masking
- None (open label)
- Enrolment
- 1,478 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Derek R Principal Investigator, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06103500
- Sponsor's protocol ID
- 20230322-01T
- Acronym
- IDEAS-CRXO
- Status last verified
- Oct 2026
- First submitted
- 18 Oct 2023
- Last updated
- 19 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis: A Cluster Randomized Cross-Over Trial (IDEAS-CRXO)
- ClinicalTrials.gov ID
- NCT06103500
- Acronym / sponsor ID
- IDEAS-CRXO / 20230322-01T
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding.
- Enrolment
- 1,478 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- 21 May 2024 (actual)
- Primary completion
- 20 Apr 2025 (actual)
- Study completion
- 28 Nov 2025 (actual)
- First posted
- 26 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Cluster Randomized Cross-Over Trial
| Arm | Type | Receives |
|---|---|---|
| Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis | Experimental | Other: Clinical Decision Support Algorithm for Empiric Antibiotics in SepsisThe 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. |
| Standard of Care | No intervention | –Non-intervention group. No decision support is provided. Patient care is routine. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- Admitted
- Age >18 years old
- Newly started (within 24 hours of assessment for eligibility) on at least one of the following antibiotic(s):
- Blood cultures ordered (within 12 hours before or after initiation of index antibiotics).
- Pregnancy/breastfeeding
Key exclusion criteria (0 listed)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Clinical Decision Support Algorithm for Empiric Antibiotics in SepsisAlso: Decision Support ToolA clinical decision support algorithm for empiric antibiotic selection in suspected infection. | Other | Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis |
Primary outcome
Number of Patients De-escalated
Time frame: 48 hours
De-escalation from empiric antibiotic regimen at 48 hours (or at time of discharge if earlier) from receipt of index antibiotics [Binary].
19 secondary outcomes
Time to adequate therapy for positive blood cultures
Time frame: 0-7 days
Time to adequate therapy for positive non-screening cultures
Time frame: 0-7 days
Number of Patients Receiving Adequate Therapy at 48 hours based on blood cultures
Time frame: 48 hours
Number of Patients Receiving Adequate Therapy at 48 hours based on non-screening cultures
Time frame: 48 hours
Mortality
Time frame: 90 days
Length of stay
Time frame: 0-90 days
De-escalation extent
Time frame: 48 hours
Antibiotic spectrum at completion
Time frame: Completion of therapy, up to 90 days
Number of Patients with C.difficile Infection
Time frame: 90 days
Number of Patients Requiring Dialysis
Time frame: 90 days
Days of antibiotic therapy
Time frame: End of index admission, up to 90 days
Number of Patients with Antibiotic Escalation
Time frame: 48 hours
Time to De-escalation
Time frame: 0-7 days
Number of Patients with Recommended change in Gram-negative coverage
Time frame: At time of assessment (0 days)
Number of Patients with Accepted change in Gram-negative coverage
Time frame: Within 24 hours
Number of Patients with Recommended change in Gram-positive coverage
Time frame: At time of assessment (0 days)
Number of Patients with Accepted change in Gram-positive coverage
Time frame: Within 24 hours
Number of Patients with Non-recommended escalation at 7 days
Time frame: 7 days
Number of Patients with ICU admit or mortality
Time frame: 7 days
Results and safety
The study was stopped early (reason given: Funding.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Derek R Principal Investigator principal investigator
Ottawa Hospital Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis in people with Sepsis and Bacterial Infections, run by Ottawa Hospital Research Institute at 3 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 17 inclusion and 0 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early (reason given: Funding.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Patients De-escalated (time frame: 48 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2026.