Antimicrobial De-escalation Strategy in Medical Patients

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Fraser Health.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Vancouver Foundation
Information provided by:
Fraser Health
ClinicalTrials.gov Identifier:
NCT01066013
First received: February 1, 2010
Last updated: August 17, 2010
Last verified: January 2010
  Purpose

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 Intervention
Infections
Other: Antimicrobial de-escalation strategy

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Antimicrobial De-escalation Strategy in Medical Patients

Resource links provided by NLM:


Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team. [ Time Frame: 7 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Clinical efficacy (clinical improvement or complete resolution of infection) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • Cost and consumption (usage data) of antibiotics [ Time Frame: 7 days ] [ Designated as safety issue: No ]
  • All cause mortality [ Time Frame: 14 days ] [ Designated as safety issue: No ]
  • Length of stay in the hospital [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: February 2010
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: May 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

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.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

Responsible Party: Anisha Lakhani, Fraser Health Authority
ClinicalTrials.gov Identifier: NCT01066013     History of Changes
Other Study ID Numbers: FHREB 2009-093
Study First Received: February 1, 2010
Last Updated: August 17, 2010
Health Authority: Canada: Ethics Review Committee

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
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on August 28, 2014