Antimicrobial De-escalation Strategy in Medical Patients
Information source: Fraser Health
ClinicalTrials.gov processed this data on August 23, 2015 Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Infections
Intervention: Antimicrobial de-escalation strategy (Other)
Phase: N/A
Status: Active, not recruiting
Sponsored by: Fraser Health
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.
Clinical Details
Official title: Antimicrobial De-escalation Strategy in Medical Patients
Study design: Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Primary outcome: Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.
Secondary outcome: Clinical efficacy (clinical improvement or complete resolution of infection)Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation Cost and consumption (usage data) of antibiotics All cause mortality Length of stay in the hospital
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
Minimum age: 19 Years.
Maximum age: N/A.
Gender(s): Both.
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
Locations and Contacts
Additional Information
Starting date: February 2010
Last updated: August 17, 2010
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