Antimicrobial De-escalation Strategy in Medical Patients

Not Applicable

• Conditions: Infections
• Interventions: Other: Antimicrobial de-escalation strategy

• Registration Number: NCT01066013
• Lead Sponsor: Fraser Health

Brief Summary

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

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.

Study Timeline

• Status Verified: 2010-01
• Study Start: 2010-02
• Study First Submitted: 2010-02-01
• Study First Submitted QC: 2010-02-08
• Study First Posted: 2010-02-10
• Primary Completion: 2010-05
• Study Completion: 2010-06
• Last Update Submitted: 2010-08-17
• Last Update Posted: 2010-08-18

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Prospective Antimicrobial de-escalation arm	Antimicrobial de-escalation strategy	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).

Primary Outcome Measures

Name	Time	Method
Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.	7 days

Secondary Outcome Measures

Name	Time	Method
Length of stay in the hospital	14 days
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