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Prospective Validation of the Shamir Resistance Calculator: an Interventional Crossover Trial to Improve Empiric Prescription of Antimicrobials in Acute Care Hospitals.

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other
Study Type: Observational
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Israel
Shamir Medical Center (Assaf Harofeh)
RECRUITING
Be’er Ya‘aqov
Hadassah Medical Organization
RECRUITING
Jerusalem
Contact Information
Primary
Dror Marchaim, M.D
drormarchaim@shamir.gov.il
+972-8-9778146
Backup
Ron Finkenberg
ronfin@shamir.gov.il
+97289778248
Time Frame
Start Date: 2023-07-03
Estimated Completion Date: 2025-01
Participants
Target number of participants: 1500
Treatments
Intervention group
Septic patients from 2 sites, who are hospitalized and require empiric antibiotic treatment, whose primary physician was assisted by the Shamir Resistance Calculator.
Control group
Septic patients from 2 sites, who are hospitalized and require empiric antibiotic treatment, whose primary physician was not assisted by the Shamir Resistance Calculator.
Related Therapeutic Areas
Sponsors
Collaborators: Hadassah Medical Organization
Leads: Dror MarChaim, MD

This content was sourced from clinicaltrials.gov