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Trial record 31 of 10491 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

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.


Condition or disease Intervention/treatment Phase
Infection, Bacterial Other: Compulsory CDSS Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1257 participants
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
Official Title: Effective Antimicrobial StewaRdship StrategIES (ARIES): Cluster-randomized Trial of a Computerized Decision Support System Versus Antibiotic Prospective Review and Feedback in Antimicrobial Stewardship
Actual Study Start Date : March 1, 2017
Actual Primary Completion Date : September 30, 2017
Actual Study Completion Date : February 28, 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics

Arm Intervention/treatment
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
Other: Compulsory CDSS
Compulsory CDSS use with prospective review feedback in patients prescribed with piperacillin tazobactam or carbapenems




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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".

  8. 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

  9. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04011657


Locations
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Singapore
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Sponsors and Collaborators
Tan Tock Seng Hospital

Publications:

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Responsible Party: Tan Tock Seng Hospital
ClinicalTrials.gov Identifier: NCT04011657     History of Changes
Other Study ID Numbers: 2015/00671
First Posted: July 8, 2019    Key Record Dates
Last Update Posted: July 9, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized data can be made available only after project agreement is made

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Tan Tock Seng Hospital:
computerized decision support
prospective review and feedback
antimicrobial stewardship

Additional relevant MeSH terms:
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Bacterial Infections
Anti-Bacterial Agents
Anti-Infective Agents