Integrated Clinical Decision Support for Empiric Antibiotic Selection in Sepsis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

1440 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-05-21

Study Completion Date

2025-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Early Optimization of Ceftazidime Regimen in Critical Care

NCT07085624

Infection in ICU Sepsis Septic Shock +1 more

NOT_YET_RECRUITING NA

Evaluation of the Performance of the IDBIORIV Method in Pathogen Identification and Antibiotic Susceptibility Testing in Patients With Sepsis

NCT06219135

Sepsis

RECRUITING

Days Alive and Out of Hospital for Patients With Sepsis

NCT04567433

Sepsis Septic Shock

COMPLETED

Antibiotic Administration and Blood Culture Positivity in Severe Sepsis and Septic Shock

NCT01867905

Severe Sepsis Septic Shock Bacteremia

COMPLETED

Empiric Antibiotic Treatment for Septic Patients in the Intensive Care Unit

NCT05924126

Septic Patients Admitted to the ICU

RECRUITING

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Sepsis Bacterial Infections Community-Acquired Infections Hospital Infection

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Cluster Randomized Cross-Over Trial

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Statistical analyst will be blind to treatment allocation.

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis

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 Type EXPERIMENTAL

Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis

Intervention Type OTHER

A clinical decision support algorithm for empiric antibiotic selection in suspected infection.

Standard of Care

Non-intervention group. No decision support is provided. Patient care is routine.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

Clinical Decision Support Algorithm for Empiric Antibiotics in Sepsis

A clinical decision support algorithm for empiric antibiotic selection in suspected infection.

Intervention Type OTHER

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

Decision Support Tool

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.

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.

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No