Actively Recruiting

Age: 18Years +
All Genders
NCT05304221

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

Led by Dror MarChaim, MD · Updated on 2024-07-31

1500

Participants Needed

2

Research Sites

78 weeks

Total Duration

On this page

Sponsors

D

Dror MarChaim, MD

Lead Sponsor

H

Hadassah Medical Organization

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adult patients aged over 18 years
  • Patients hospitalized at Shamir Medical Center or Hadassah Medical Organization during the study period
  • Patients who started empiric antibiotic treatment due to acute sepsis
  • Sepsis defined by established clinical criteria
  • Patients admitted to the emergency room but not discharged home or transferred to another facility without hospitalization
Not Eligible

You will not qualify if you...

History of severe allergic reactions to study medication Currently pregnant or breastfeeding Recent participation in another clinical trial within the last 30 days Presence of uncontrolled medical conditions that could affect safety

AI-Screening

AI-Powered Screening

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Trial Site Locations

Total: 2 locations

1

Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, Israel, 70300

Actively Recruiting

2

Hadassah Medical Organization

Jerusalem, Israel, 91120

Actively Recruiting

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Research Team

D

Dror Marchaim, M.D

CONTACT

R

Ron Finkenberg

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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