Validating an electronic tool to improve antibiotic treatment for sepsis
Prospective Validation of the "Shamir Resistance Calculator": an Interventional Crossover Trial to Improve Empiric Prescription of Antimicrobials in Acute Care Hospitals.
This study is testing a new electronic tool to see if it can help doctors start the right antibiotics faster for adults with sepsis in the hospital.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1500 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Assaf-Harofeh Medical Center Government |
| Locations | 2 sites (Be’er Ya‘aqov and 1 other locations) |
| Trial ID | NCT05304221 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to validate the 'Shamir Resistance Calculator' in a prospective crossover design to enhance the speed of appropriate antimicrobial therapy initiation in hospitalized patients with sepsis. The primary objective is to determine if the calculator can shorten the time to start effective antibiotics, while secondary objectives include assessing its impact on the acquisition of multi-drug resistant organisms, the use of broad-spectrum antibiotics, the incidence of Clostridiodes difficile infections, and in-hospital mortality rates. The study will involve adult patients admitted to specific medical centers who are diagnosed with acute sepsis and require empirical antibiotic treatment.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old who are hospitalized with acute sepsis and require empirical antibiotic therapy.
Not a fit: Patients who are discharged from the emergency room without being admitted or those receiving antibiotics as part of a main-consolidative or pre-emptive regimen may not benefit from this study.
Why it matters
Potential benefit: If successful, this tool could significantly reduce the time to effective treatment for sepsis, potentially improving patient outcomes and reducing complications.
How similar studies have performed: While the approach of using electronic calculators for antibiotic resistance is gaining traction, this specific validation of the 'Shamir Resistance Calculator' is novel and has not been extensively tested in prior studies.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Adult patients (age\>18 years) * Patients who are hospitalized at Shamir MC or at Hadassah Medical Organization during the study period. o Patients admitted to the ER and later-on discharged home, or discharged from the ER to a different facility, will be excluded as it will not enable us to follow all the designated outcomes. * Patients for which antibiotic treatment was initiated, empirically, due to acute sepsis. * Patients for which antibiotics were initiated as part of a main-consolidative regimen, or as part of a pre-emptive regimen, will not be included in the study. * Sepsis will be defined in accordance to established criteria1. Exclusion Criteria: \-
Where this trial is running
Be’er Ya‘aqov and 1 other locations
- Shamir Medical Center (Assaf Harofeh) — Be’er Ya‘aqov, Israel (Recruiting)
- Hadassah Medical Organization — Jerusalem, Israel (Recruiting)
Study contacts
- Principal investigator: Dror MarChaim, M.D — Assaf-Harofeh Medical Center
- Study coordinator: Dror Marchaim, M.D
- Email: drormarchaim@shamir.gov.il
- Phone: +972-8-9778146
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.