Antimicrobial De-escalation Strategy in Medical Patients

August 17, 2010 updated by: Fraser Health
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

100

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Prospective Antimicrobial de-escalation arm
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
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.
NO_INTERVENTION: Restrospective control arm
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?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Fraser Health

Collaborators

Vancouver Foundation

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2010

Primary Completion (ANTICIPATED)

May 1, 2010

Study Completion (ANTICIPATED)

June 1, 2010

Study Registration Dates

First Submitted

February 1, 2010

First Submitted That Met QC Criteria

February 8, 2010

First Posted (ESTIMATE)

February 10, 2010

Study Record Updates

Last Update Posted (ESTIMATE)

August 18, 2010

Last Update Submitted That Met QC Criteria

August 17, 2010

Last Verified

January 1, 2010

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FHREB 2009-093

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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