Effective Antimicrobial StewaRdship StrategIES (ARIES)

NCT04011657 | Completed DMC

• 1 other identifier: 2015/00671
• Study Type: interventional
• Target: 1,257
• Locations: 1 country
• Sites: 1

Brief Summary

Background Prospective review and feedback (PRF) of antibiotic prescriptions is a labor-intensive core strategy of antimicrobial stewardship (AMS). The investigators hypothesized that a computerized decision support system (CDSS) providing recommendations for antibiotics, investigations and referrals would reduce the requirement for PRF without causing harm. Methods A parallel-group, 1:1 block-cluster randomized, cross-over study was conducted in 32 medical and surgical wards from March to August 2017. The intervention arm comprised voluntary use of CDSS at first prescription of piperacillin-tazobactam or a carbapenem, while the control arm was compulsory CDSS. PRF was continued for both arms. Primary outcome was 30-day mortality.

Conditions

Infection, Bacterial

Keywords

computerized decision support; prospective review and feedback; antimicrobial stewardship

Outcome Measures

Primary Outcomes (1)

• 30-day mortality

  Death at 30 days

  Follow-up up to 30 days from the start date of the first episode of piperacillin-tazobactam or carbapenem use

Secondary Outcomes (9)

• 7-day clinical response

  Follow-up up to 7 days from the date of the first episode of piperacillin-tazobactam or carbapenem use

• 30-day re-infection

  Re-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use

• 30-day readmission

  Readmissions 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use

• length of stay

  It is assessed from the date of admission till the date of discharge or up to 6 months

• 6-months incidence of multi-drug resistant organisms

  up to 6 months (Clinical cultures only)

Study Arms (2)

Voluntary CDSS

EXPERIMENTAL

Voluntary use of computerized decision support with prospective review and feedback

Other: Compulsory CDSS

Compulsory CDSS

NO INTERVENTION

Compulsory use of computerized decision support with prospective review and feedback

Interventions

Compulsory CDSS OTHER

Compulsory CDSS use with prospective review feedback in patients prescribed with piperacillin tazobactam or carbapenems

Voluntary CDSS

Eligibility Criteria

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

You may qualify if:

• Patients who are started on the 1st episode of piperacillin-tazobactam or carbapenem during the study period.
• Medical and surgical wards

You may not qualify if:

• Intensive care unit (ICU), high dependency and step-down care wards

Sponsors & Collaborators

• Tan Tock Seng Hospital: lead

Study Sites (1)

Tan Tock Seng Hospital

Singapore, 308433, Singapore

Location

Related Publications (8)

• Barlam TF, Cosgrove SE, Abbo LM, MacDougall C, Schuetz AN, Septimus EJ, Srinivasan A, Dellit TH, Falck-Ytter YT, Fishman NO, Hamilton CW, Jenkins TC, Lipsett PA, Malani PN, May LS, Moran GJ, Neuhauser MM, Newland JG, Ohl CA, Samore MH, Seo SK, Trivedi KK. Implementing an Antibiotic Stewardship Program: Guidelines by the Infectious Diseases Society of America and the Society for Healthcare Epidemiology of America. Clin Infect Dis. 2016 May 15;62(10):e51-77. doi: 10.1093/cid/ciw118. Epub 2016 Apr 13.

  PMID: 27080992 BACKGROUND

• Davey P, Marwick CA, Scott CL, Charani E, McNeil K, Brown E, Gould IM, Ramsay CR, Michie S. Interventions to improve antibiotic prescribing practices for hospital inpatients. Cochrane Database Syst Rev. 2017 Feb 9;2(2):CD003543. doi: 10.1002/14651858.CD003543.pub4.

  PMID: 28178770 BACKGROUND

• Lew KY, Ng TM, Tan M, Tan SH, Lew EL, Ling LM, Ang B, Lye D, Teng CB. Safety and clinical outcomes of carbapenem de-escalation as part of an antimicrobial stewardship programme in an ESBL-endemic setting. J Antimicrob Chemother. 2015 Apr;70(4):1219-25. doi: 10.1093/jac/dku479. Epub 2014 Dec 3.

  PMID: 25473028 BACKGROUND

• Schuts EC, Hulscher MEJL, Mouton JW, Verduin CM, Stuart JWTC, Overdiek HWPM, van der Linden PD, Natsch S, Hertogh CMPM, Wolfs TFW, Schouten JA, Kullberg BJ, Prins JM. Current evidence on hospital antimicrobial stewardship objectives: a systematic review and meta-analysis. Lancet Infect Dis. 2016 Jul;16(7):847-856. doi: 10.1016/S1473-3099(16)00065-7. Epub 2016 Mar 3.

  PMID: 26947617 BACKGROUND

• Yong MK, Buising KL, Cheng AC, Thursky KA. Improved susceptibility of Gram-negative bacteria in an intensive care unit following implementation of a computerized antibiotic decision support system. J Antimicrob Chemother. 2010 May;65(5):1062-9. doi: 10.1093/jac/dkq058. Epub 2010 Mar 9.

  PMID: 20215130 BACKGROUND

• Thursky K. Use of computerized decision support systems to improve antibiotic prescribing. Expert Rev Anti Infect Ther. 2006 Jun;4(3):491-507. doi: 10.1586/14787210.4.3.491.

  PMID: 16771625 BACKGROUND

• Leibovici L, Kariv G, Paul M. Long-term survival in patients included in a randomized controlled trial of TREAT, a decision support system for antibiotic treatment. J Antimicrob Chemother. 2013 Nov;68(11):2664-6. doi: 10.1093/jac/dkt222. Epub 2013 Jun 5.

  PMID: 23743088 BACKGROUND

• Chow AL, Lye DC, Arah OA. Mortality Benefits of Antibiotic Computerised Decision Support System: Modifying Effects of Age. Sci Rep. 2015 Nov 30;5:17346. doi: 10.1038/srep17346.

  PMID: 26617195 BACKGROUND

MeSH Terms

Conditions

Bacterial Infections

Condition Hierarchy (Ancestors)

Bacterial Infections and Mycoses; Infections

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: A parallel-group, 1:1 block-cluster randomized, cross-over study
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 1, 2019
• First Posted: July 8, 2019
• Study Start: March 1, 2017
• Primary Completion: September 30, 2017
• Study Completion: February 28, 2018
• Last Updated: November 14, 2019

Record last verified: 2019-11

Data Sharing

• IPD Sharing: Will share

Locations

SG (1)