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

NCT05304221 | Recruiting

• 1 other identifier: 0063-22-ASF
• Study Type: observational
• Target: 1,500
• Locations: 1 country
• Sites: 2

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 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

Sepsis

Keywords

MDRO; Antimicrobial Stewardship; Antimicrobial Resistance; Resistance Calculator

Outcome Measures

Primary Outcomes (1)

• Time to initiation of appropriate antimicrobials.

  The median number of days from date of enrollment to the day that the first antibiotic with in-vitro susceptibility per microbiology report was initiated.

  15 months study's period.

Secondary Outcomes (4)

• Cases of new acquisitions of MDRO by patients.

  15 months study's period.

• The amount of empiric usage of broad-spectrum agents.

  15 months study's period.

• Acute Clostridiodes Difficile infections.

  15 months study's period.

• In-hospital mortality

  15 months study's period.

Study Arms (2)

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.

Other: 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.

Interventions

Shamir Resistance Calculator OTHER

An on-line calculator which is free and accessible from all devices, which may predict the risk of MDRO infection upon admission, and the risk of nosocomial XDRO infection during the hospitalization. The calculator contains only parameters that could be extracted bedside, at the first presentation of a septic patient, including the ability to conduct a complete assessment also among patients with reduced consciousness and/or cognition.

Intervention group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients above 18 years old will be included in the study. No diversity issues are relevant.

You may qualify if:

• 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.

Sponsors & Collaborators

• Dror MarChaim, MD: lead
• Hadassah Medical Organization: collaborator

Study Sites (2)

Shamir Medical Center (Assaf Harofeh)

Be’er Ya‘aqov, 70300, Israel

RECRUITING

Hadassah Medical Organization

Jerusalem, 91120, Israel

RECRUITING

Related Publications (10)

• Marchaim D, Chopra T, Bogan C, Bheemreddy S, Sengstock D, Jagarlamudi R, Malani A, Lemanek L, Moshos J, Lephart PR, Ku K, Hasan A, Lee J, Khandker N, Blunden C, Geffert SF, Moody M, Hiro R, Wang Y, Ahmad F, Mohammadi T, Faruque O, Patel D, Pogue JM, Hayakawa K, Dhar S, Kaye KS. The burden of multidrug-resistant organisms on tertiary hospitals posed by patients with recent stays in long-term acute care facilities. Am J Infect Control. 2012 Oct;40(8):760-5. doi: 10.1016/j.ajic.2011.09.011. Epub 2012 Jan 30.

  PMID: 22285709 BACKGROUND

• Paul M, Shani V, Muchtar E, Kariv G, Robenshtok E, Leibovici L. Systematic review and meta-analysis of the efficacy of appropriate empiric antibiotic therapy for sepsis. Antimicrob Agents Chemother. 2010 Nov;54(11):4851-63. doi: 10.1128/AAC.00627-10. Epub 2010 Aug 23.

  PMID: 20733044 BACKGROUND

• Pogue JM, Kaye KS, Cohen DA, Marchaim D. Appropriate antimicrobial therapy in the era of multidrug-resistant human pathogens. Clin Microbiol Infect. 2015 Apr;21(4):302-12. doi: 10.1016/j.cmi.2014.12.025. Epub 2015 Jan 14.

  PMID: 25743999 BACKGROUND

• Aviv T, Lazarovitch T, Katz D, Zaidenstein R, Dadon M, Daniel C, Tal-Jasper R, Kaye KS, Marchaim D. The epidemiological impact and significance of carbapenem resistance in Pseudomonas aeruginosa bloodstream infections: a matched case-case-control analysis. Infect Control Hosp Epidemiol. 2018 Oct;39(10):1262-1265. doi: 10.1017/ice.2018.181. Epub 2018 Aug 14.

  PMID: 30103833 BACKGROUND

• Schwaber MJ, Carmeli Y. Mortality and delay in effective therapy associated with extended-spectrum beta-lactamase production in Enterobacteriaceae bacteraemia: a systematic review and meta-analysis. J Antimicrob Chemother. 2007 Nov;60(5):913-20. doi: 10.1093/jac/dkm318. Epub 2007 Sep 11.

  PMID: 17848376 BACKGROUND

• Marchaim D, Gottesman T, Schwartz O, Korem M, Maor Y, Rahav G, Karplus R, Lazarovitch T, Braun E, Sprecher H, Lachish T, Wiener-Well Y, Alon D, Chowers M, Ciobotaro P, Bardenstein R, Paz A, Potasman I, Giladi M, Schechner V, Schwaber MJ, Klarfeld-Lidji S, Carmeli Y. National multicenter study of predictors and outcomes of bacteremia upon hospital admission caused by Enterobacteriaceae producing extended-spectrum beta-lactamases. Antimicrob Agents Chemother. 2010 Dec;54(12):5099-104. doi: 10.1128/AAC.00565-10. Epub 2010 Sep 13.

  PMID: 20837757 BACKGROUND

• Marchaim D, Kaye KS, Fowler VG, Anderson DJ, Chawla V, Golan Y, Karchmer AW, Carmeli Y. Case-control study to identify factors associated with mortality among patients with methicillin-resistant Staphylococcus aureus bacteraemia. Clin Microbiol Infect. 2010 Jun;16(6):747-52. doi: 10.1111/j.1469-0691.2009.02934.x. Epub 2009 Sep 11.

  PMID: 19723135 BACKGROUND

• Tal-Jasper R, Katz DE, Amrami N, Ravid D, Avivi D, Zaidenstein R, Lazarovitch T, Dadon M, Kaye KS, Marchaim D. Clinical and Epidemiological Significance of Carbapenem Resistance in Acinetobacter baumannii Infections. Antimicrob Agents Chemother. 2016 Apr 22;60(5):3127-31. doi: 10.1128/AAC.02656-15. Print 2016 May.

  PMID: 26883694 BACKGROUND

• Zilberman-Itskovich S, Strul N, Chedid K, Martin ET, Shorbaje A, Vitkon-Barkay I, Marcus G, Michaeli L, Broide M, Yekutiel M, Zohar Y, Razin H, Low A, Strulovici A, Israeli B, Geva G, Katz DE, Ben-Chetrit E, Dodin M, Dhar S, Parsons LM, Ramos-Mercado A, Kaye KS, Marchaim D. A "resistance calculator": Simple stewardship intervention for refining empiric practices of antimicrobials in acute-care hospitals. Infect Control Hosp Epidemiol. 2021 Sep;42(9):1082-1089. doi: 10.1017/ice.2020.1372. Epub 2021 Mar 19.

  PMID: 33736724 BACKGROUND

• Purssell E, Drey N, Chudleigh J, Creedon S, Gould DJ. The Hawthorne effect on adherence to hand hygiene in patient care. J Hosp Infect. 2020 Oct;106(2):311-317. doi: 10.1016/j.jhin.2020.07.028. Epub 2020 Aug 5.

  PMID: 32763330 BACKGROUND

Related Links

• WHO publishes list of bacteria for which new antibiotics are urgently needed. 2017

MeSH Terms

Conditions

Sepsis

Condition Hierarchy (Ancestors)

Infections; Systemic Inflammatory Response Syndrome; Inflammation; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Dror MarChaim, M.D

  Assaf-Harofeh Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Dror Marchaim, M.D

CONTACT

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

Ron Finkenberg

CONTACT

+97289778248; ronfin@shamir.gov.il

Study Design

• Study Type: observational
• Observational Model: CASE CROSSOVER
• Time Perspective: PROSPECTIVE
• Target Duration: 12 Months
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Head of the Unit of Infection Control & Prevention

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 31, 2022
• Study Start: July 3, 2023
• Primary Completion: October 1, 2024
• Study Completion: January 1, 2025
• Last Updated: July 31, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

IL (2)