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Trial record 31 of 10427 for:    Anti-Infective Agents AND Bacterial

Effective Antimicrobial StewaRdship StrategIES (ARIES) (ARIES)

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ClinicalTrials.gov Identifier: NCT04011657
Recruitment Status : Completed
First Posted : July 8, 2019
Last Update Posted : July 9, 2019
Sponsor:
Information provided by (Responsible Party):
Tan Tock Seng Hospital

Tracking Information
First Submitted Date  ICMJE July 1, 2019
First Posted Date  ICMJE July 8, 2019
Last Update Posted Date July 9, 2019
Actual Study Start Date  ICMJE March 1, 2017
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
30-day mortality [ Time Frame: Follow-up up to 30 days from the start date of the first episode of piperacillin-tazobactam or carbapenem use ]
Death at 30 days
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT04011657 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: July 4, 2019)
  • 7-day clinical response [ Time Frame: Follow-up up to 7 days from the date of the first episode of piperacillin-tazobactam or carbapenem use ]
    resolution of systemic inflammatory response syndrome
  • 30-day re-infection [ Time Frame: Re-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use ]
    Re-start of piperacilin-tazobactam or carbapenem 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use
  • 30-day readmission [ Time Frame: Readmissions 30 days after the cessation of first episode of piperacillin-tazobactam or carbapenem use ]
    Readmission after the cessation of first episode of piperacillin-tazobactam or carbapenem use
  • length of stay [ Time Frame: It is assessed from the date of admission till the date of discharge or up to 6 months ]
    Duration of admission
  • 6-months incidence of multi-drug resistant organisms [ Time Frame: up to 6 months (Clinical cultures only) ]
    MRSA, VRE, ESBL, MDR-A. baumannii, XDR- A baumannii, MDR- P. aeruginosa, XDR-P aeruginosa, C difficile , Carbapenem resistant enterobacterales
  • Diarrhea this admission [ Time Frame: From the start date from the first episode of piperacillin-tazobactam or carbapenem use until the discharge date or up to 6 months whichever occurred earlier ]
    Incidence of diarrhea from start of first episode of piperacillin-tazobactam or carbapenem use till discharge
  • Appropriateness of antibiotics [ Time Frame: It is assessed only once at the point of the first episode of piperacillin-tazobactam or carbapenem use in the index admission. It is only assessed once till discharge or up to 6 months ]
    first episode of piperacillin-tazobactam or carbapenem use according to hospital guidelines. Appropriateness will be described as "yes" or "no".
  • Index antibiotic days of therapy, [ Time Frame: From the start date of the first episode of piperacillin-tazobactam or carbapenem use to the end date of this antibiotic which is followed up till discharge or up to 6 months. ]
    Duration of the first episode of piperacillin-tazobactam or carbapenem use
  • Gross hospitalization costs [ Time Frame: Gross hospitalization costs incured from date of admission till date of discharge or up to 6 months ]
    Gross hospitalization costs
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Effective Antimicrobial StewaRdship StrategIES (ARIES)
Official Title  ICMJE Effective Antimicrobial StewaRdship StrategIES (ARIES): Cluster-randomized Trial of a Computerized Decision Support System Versus Antibiotic Prospective Review and Feedback in Antimicrobial Stewardship
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 control arm comprised voluntary use of CDSS at first prescription of piperacillin-tazobactam or a carbapenem, while the intervention arm was compulsory CDSS. PRF was continued for both arms. Primary outcome was 30-day mortality.

Detailed Description

Increasing antimicrobial resistance due to inappropriate antimicrobial use is a global concern. Multi-disciplinary antimicrobial stewardship teams have become an integral part of the response to this issue. Through prospective review of antibiotic prescriptions and feedback (PRF) to healthcare providers, antimicrobial stewardship has been shown to improve clinical response, reduce adverse effects and mortality. However, this strategy is labor-intensive to implement and skilled healthcare workers are an expensive and scarce resource. Antibiotic computerized decision support systems (CDSS) have been used to facilitate these processes and may circumvent the limitations of lack of manpower. In previous studies, CDSS led to increased susceptibility of Pseudomonas aeruginosa to imipenem and Enterobacteriaceae to gentamicin and ciprofloxacin, and an overall reduction in broad-spectrum antibiotic use. CDSS could improve clinical outcomes. Currently, there are limited studies comparing the combined effects of these two strategies.

At Tan Tock Seng Hospital, a university teaching hospital in Singapore, antimicrobial stewardship has focused on PRF by a multi-disciplinary team since 2009. This team reviews piperacillin-tazobactam and carbapenem orders against hospital antibiotic guidelines from day two of antibiotic prescription. In March 2010, we implemented CDSS triggered at the point of antibiotic ordering and compulsory for the prescriber to review. Prescribers are free to accept or reject the CDSS recommendations. While PRF and CDSS are performed following the same institutional guidelines, there may be differences in physicians' acceptance of recommendations and the accessibility to recommendations between these two interventions. In previous studies, PRF recommendations had an acceptance of 60-70% while compulsory CDSS was 40%. The investigators hypothesized that compulsory CDSS and PRF would improve clinical outcomes compared with voluntary CDSS and PRF, and compulsory CDSS would improve appropriate antibiotic practice and reduce the requirement for subsequent PRF.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Masking Description:
A parallel-group, 1:1 block-cluster randomized, cross-over study
Primary Purpose: Health Services Research
Condition  ICMJE Infection, Bacterial
Intervention  ICMJE Other: Compulsory CDSS
Compulsory CDSS use with prospective review feedback in patients prescribed with piperacillin tazobactam or carbapenems
Study Arms  ICMJE
  • No Intervention: Voluntary CDSS
    Voluntary use of computerized decision support with prospective review and feedback
  • Experimental: Compulsory CDSS
    Compulsory use of computerized decision support with prospective review and feedback
    Intervention: Other: Compulsory CDSS
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 4, 2019)
1257
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE February 28, 2018
Actual Primary Completion Date September 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  • Intensive care unit (ICU), high dependency and step-down care wards
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Singapore
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04011657
Other Study ID Numbers  ICMJE 2015/00671
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Anonymized data can be made available only after project agreement is made
Responsible Party Tan Tock Seng Hospital
Study Sponsor  ICMJE Tan Tock Seng Hospital
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Tan Tock Seng Hospital
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP