Actively Recruiting

Age: 18Years +
All Genders
ID05304221

Prospective Validation of the Shamir Resistance Calculator to Improve Empiric Antimicrobial Prescription in Hospitalized Adults with Sepsis

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

1500

Participants Needed

2

Research Sites

13 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

Researchers are evaluating the Shamir Resistance Calculator in a prospective cluster-randomized controlled crossover trial to improve the timing of appropriate antimicrobial treatment for hospitalized adult patients with sepsis. The study aims to shorten delays in starting effective antibiotics, reduce new infections with multi-drug resistant organisms (MDRO), decrease the use of broad-spectrum antibiotics, lower rates of acute Clostridiodes difficile infections, and reduce in-hospital mortality. This approach addresses a major global health challenge related to antibiotic resistance and aims to support physicians in making better empiric treatment decisions. The intervention involves the use of an online, freely accessible calculator that predicts the risk of MDRO infection upon admission and the risk of nosocomial extensively drug resistant organism (XDRO) infection during hospitalization. The calculator uses bedside clinical parameters, including assessments for patients with reduced consciousness. The trial compares periods when physicians use the calculator to assist antibiotic prescribing with periods when they do not, using a crossover design across two hospital sites. Each intervention period lasts six months, separated by one-month washout intervals. Participants are adult patients hospitalized with acute sepsis who require empiric antibiotic treatment. The study collects data over 15 months, tracking time to appropriate antibiotic initiation, new MDRO acquisitions, use of broad-spectrum agents, occurrences of acute C. difficile infections, and in-hospital mortality. The calculator's usage by prescribers is monitored electronically, and no individual consent is required as the intervention poses minimal risk. Safety and outcomes are analyzed to evaluate the calculator's impact on clinical care.

CONDITIONS

Brief 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 (age >18 years)
  • Hospitalized at Shamir Medical Center or Hadassah Medical Organization during the study period
  • Patients started on empiric antibiotic treatment due to acute sepsis
  • Sepsis defined by established criteria
  • Patients admitted to the emergency room and later discharged home or to another facility are excluded
Not Eligible

You will not qualify if you...

  • None specified

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

Participants are identified when hospitalized with acute sepsis requiring empiric antibiotic treatment.

Monitoring

Duration - Up to 15 months during the study period

Participants are observed during hospitalization to assess the use and impact of the Shamir Resistance Calculator on antimicrobial prescriptions and clinical outcomes.

Participants receive routine clinical care with monitoring of antibiotic use and infection outcomes throughout hospitalization.

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

R

Ron Finkenberg

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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Published Research Related To This Trial

The burden of multidrug-resistant organisms on tertiary hospitals posed by patients with recent stays in long-term acute care facilities.

Dror Marchaim, Teena Chopra, Christopher Bogan...

https://pubmed.ncbi.nlm.nih.gov/22285709

The epidemiological impact and significance of carbapenem resistance in Pseudomonas aeruginosa bloodstream infections: a matched case-case-control analysis.

Tzach Aviv, Tsillia Lazarovitch, David Katz...

https://pubmed.ncbi.nlm.nih.gov/30103833

Mortality and delay in effective therapy associated with extended-spectrum beta-lactamase production in Enterobacteriaceae bacteraemia: a systematic review and meta-analysis.

Mitchell J Schwaber, Yehuda Carmeli

https://pubmed.ncbi.nlm.nih.gov/17848376

National multicenter study of predictors and outcomes of bacteremia upon hospital admission caused by Enterobacteriaceae producing extended-spectrum beta-lactamases.

Dror Marchaim, Tamar Gottesman, Orna Schwartz...

https://pubmed.ncbi.nlm.nih.gov/20837757

Case-control study to identify factors associated with mortality among patients with methicillin-resistant Staphylococcus aureus bacteraemia.

D Marchaim, K S Kaye, V G Fowler...

https://pubmed.ncbi.nlm.nih.gov/19723135

A "resistance calculator": Simple stewardship intervention for refining empiric practices of antimicrobials in acute-care hospitals.

Shani Zilberman-Itskovich, Nathan Strul, Khalil Chedid...

https://pubmed.ncbi.nlm.nih.gov/33736724