Antimicrobial De-escalation Strategy in Medical Patients

Study Overview
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Brief Summary
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The purpose of this pilot study is to assess the impact of an antibiotic de-escalation strategy on the clinical outcomes (clinical cure or improvement) of medical patients related to the usage of of broad-spectrum antimicrobial agents.

Detailed Description
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This is an open-label, case-control, pilot study involving medical patients with serious infections who are prescribed meropenem or piperacillin/tazobactam, at Surrey Memorial Hospital. Patients in the experimental arm (cases) will be required to provide an informed consent. A team consisting of an infectious diseases specialist, medical microbiologist and clinical pharmacists will prospectively assess antimicrobial therapy in the enrolled subjects in the prospective arm and make recommendations for antimicrobial de-escalation. The control group will consist of subjects drawn from historic data of patients on the same medical unit(s) who will be matched based on age, sex, use of broadspectrum antibiotics (meropenem or piperacillin/tazobactam) and infectious diseases diagnosis.

Official Title
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Antimicrobial De-escalation Strategy in Medical Patients

Conditions
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Infections

Intervention / Treatment
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* Other: Antimicrobial de-escalation strategy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age 19 years and over Suspected or confirmed infection for which a Meropenem and/or Piperacillin/Tazobactam is prescribed. This will include any patient who is other concomitant antibiotic(s) such as Vancomycin Subject admitted to SMH medical unit(s) Pregnant patient (or patients wishing to become pregnant) Exclusion Criteria: Age less than 19 years Granulocytopenia (< 1x109/L) Allergy or intolerance to meropenem or piperacillin-tazobactam. Febrile Neutropenia Cystic Fibrosis

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Prospective Antimicrobial de-escalation arm<br>Antimicrobial de escalation team will assess therapy and make recommendations to (a) change to antibiotic(s) with narrow spectrum,(b) stop antibiotics, (c) order new cultures/investigations or (d) consult with specialists or ID service for full evaluation (if patient's condition is worsening). | Other: Antimicrobial de-escalation strategy<br>* The antimicrobial de-escalation team will record recommendations for de-escalation in the patient's progress notes for the attending physicians to review and act upon as appropriate. The attending physician will be responsible for making changes to antimicrobial therapy and following up on patient progress as per the usual practice.<br>|
| No Intervention: Restrospective control arm<br>The control subjects will be drawn from historic data of patients on the same medical unit(s) and will be matched based on age, antibiotics, sex, and infectious diseases diagnosis. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team. |  | 7 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical efficacy (clinical improvement or complete resolution of infection) |  | 7 days | 
| Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation |  | 7 days | 
| Cost and consumption (usage data) of antibiotics |  | 7 days | 
| All cause mortality |  | 14 days | 
| Length of stay in the hospital |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Antimicrobial De escalation, Meropenem, Piperacillin tazobactam, Medical patients, Appropriate use, Cost savings, Antimicrobial De-escalation strategy