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Antimicrobial De-escalation Strategy in Medical Patients

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ClinicalTrials.gov Identifier: NCT01066013
Recruitment Status : Unknown
Verified January 2010 by Fraser Health.
Recruitment status was:  Active, not recruiting
First Posted : February 10, 2010
Last Update Posted : August 18, 2010
Sponsor:
Collaborator:
Vancouver Foundation
Information provided by:
Fraser Health

Study Description
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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.

Condition or disease Intervention/treatment Phase
Infections Other: Antimicrobial de-escalation strategy Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antimicrobial De-escalation Strategy in Medical Patients
Study Start Date : February 2010
Estimated Primary Completion Date : May 2010
Estimated Study Completion Date : June 2010

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions
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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.


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

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

Eligibility Criteria
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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

No Contacts or Locations Provided
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Anisha Lakhani, Fraser Health Authority
ClinicalTrials.gov Identifier: NCT01066013     History of Changes
Other Study ID Numbers: FHREB 2009-093
First Posted: February 10, 2010    Key Record Dates
Last Update Posted: August 18, 2010
Last Verified: January 2010

Keywords provided by Fraser Health:
Antimicrobial De escalation
Meropenem
Piperacillin tazobactam
Medical patients
 Appropriate use
Cost savings
Antimicrobial De-escalation strategy

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