RecruitingNot Applicable

A Prospective Cluster-Randomized, Controlled Crossover Trial to Validate an Electronic "Resistance Calculator"

Israel1,500 participantsStarted 2023-07-03

Plain-language summary

Primary objective: \- Our aim is to validate the "Shamir Resistance Calculator" in a prospective crossover trial, in order to shorten the time to initiation of appropriate antimicrobials among hospitalized septic patients. Secondary objectives: \- To evaluate the impact of using the "Shamir Resistance Calculator" with regards to: * new acquisitions of multi-drug resistant organisms (MDRO) * the empiric usage of broad-spectrum agents (e.g., carbapenems, vancomycin) * acute Clostridiodes difficile infections * In-hospital mortality.

Who can participate

Age range18 Years

SexALL

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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: \-

What they're measuring

Time to initiation of appropriate antimicrobials.

Timeframe: 15 months study's period.

Trial details

NCT IDNCT05304221

SponsorDror MarChaim, MD

Sponsor typeOTHER_GOV

Study typeOBSERVATIONAL

Primary completion2024-10

Contact for this trial

Dror Marchaim, M.D

+972-8-9778146 drormarchaim@shamir.gov.il

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