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Completed

NCT Number: NCT04011657

Effective Antimicrobial StewaRdship StrategIES (ARIES)

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.

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Key information

Conditions

Infection, Bacterial Bacterial Infections Bacterial Infections and Mycoses Infections

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tan Tock Seng Hospital

Singapore, 308433

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Compulsory CDSS

Other

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

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Tan Tock Seng Hospital

Other

Registry information

Official study title

Effective Antimicrobial StewaRdship StrategIES (ARIES): Cluster-randomized Trial of a Computerized Decision Support System Versus Antibiotic Prospective Review and Feedback in Antimicrobial Stewardship

Acronym: ARIES

Important dates

Study start
2017
Primary completion
2017
Study completion
2018
First posted
Jul 8, 2019
Registry last updated
Nov 14, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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