Status:

RECRUITING

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

Lead Sponsor:

Dror MarChaim, MD

Collaborating Sponsors:

Hadassah Medical Organization

Conditions:

Sepsis

Eligibility:

All Genders

18+ years

Brief 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 hospit...

Detailed Description

2.1 List the clinical hypotheses. * Primary hypothesis: The "Shamir Resistance Calculator" will shorten the time to initiation of appropriate antimicrobials among hospitalized septic patients. * Seco...

Eligibility Criteria

Inclusion

  • 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

  • \-

Key Trial Info

Start Date :

July 3 2023

Trial Type :

OBSERVATIONAL

Allocation :

ESTIMATED

End Date :

January 1 2025

Estimated Enrollment :

1500 Patients enrolled

Trial Details

Trial ID

NCT05304221

Start Date

July 3 2023

End Date

January 1 2025

Last Update

July 31 2024

Active Locations (2)

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Page 1 of 1 (2 locations)

1

Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, Israel, 70300

2

Hadassah Medical Organization

Jerusalem, Israel, 91120