This trial is active, not recruiting.

Condition infections
Treatment antimicrobial de-escalation strategy
Sponsor Fraser Health
Collaborator Vancouver Foundation
Start date February 2010
End date May 2010
Trial size 100 participants
Trial identifier NCT01066013, FHREB 2009-093


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation non-randomized
Intervention model parallel assignment
Masking open label
Primary purpose treatment
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).
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)
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.

Primary Outcomes

Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.
time frame: 7 days

Secondary Outcomes

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

Eligibility Criteria

Male or female participants at least 19 years old.

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

Additional Information

Official title Antimicrobial De-escalation Strategy in Medical Patients
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.
Trial information was received from ClinicalTrials.gov and was last updated in August 2010.
Information provided to ClinicalTrials.gov by Fraser Health.