Antimicrobial De-escalation Strategy in Medical Patients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. 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
Vancouver Foundation
Information provided by:
Fraser Health

February 1, 2010
February 10, 2010
August 18, 2010
February 2010
May 2010   (Final data collection date for primary outcome measure)
Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team. [ Time Frame: 7 days ]
Same as current
Complete list of historical versions of study NCT01066013 on Archive Site
  • Clinical efficacy (clinical improvement or complete resolution of infection) [ Time Frame: 7 days ]
  • Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation [ Time Frame: 7 days ]
  • Cost and consumption (usage data) of antibiotics [ Time Frame: 7 days ]
  • All cause mortality [ Time Frame: 14 days ]
  • Length of stay in the hospital [ Time Frame: 14 days ]
Same as current
Not Provided
Not Provided
Antimicrobial De-escalation Strategy in Medical Patients
Antimicrobial De-escalation Strategy in Medical Patients
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.

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.

Not Applicable
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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.
  • 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).
    Intervention: Other: Antimicrobial de-escalation strategy
  • 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.
Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Unknown status
Same as current
June 2010
May 2010   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
19 Years and older   (Adult, Older Adult)
Contact information is only displayed when the study is recruiting subjects
Not Provided
FHREB 2009-093
Not Provided
Not Provided
Anisha Lakhani, Fraser Health Authority
Fraser Health
Vancouver Foundation
Not Provided
Fraser Health
January 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP