Antimicrobial De-escalation Strategy in Medical Patients
1 other identifier
interventional
100
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2010
Shorter than P25 for not_applicable
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 1, 2010
CompletedStudy Start
First participant enrolled
February 1, 2010
CompletedFirst Posted
Study publicly available on registry
February 10, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2010
CompletedAugust 18, 2010
January 1, 2010
3 months
February 1, 2010
August 17, 2010
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.
7 days
Secondary Outcomes (5)
Clinical efficacy (clinical improvement or complete resolution of infection)
7 days
Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation
7 days
Cost and consumption (usage data) of antibiotics
7 days
All cause mortality
14 days
Length of stay in the hospital
14 days
Study Arms (2)
Prospective Antimicrobial de-escalation arm
EXPERIMENTALAntimicrobial 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).
Restrospective control arm
NO INTERVENTIONThe 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.
Interventions
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.
Eligibility Criteria
You may qualify if:
- 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)
You may not qualify if:
- Age less than 19 years
- Granulocytopenia (\< 1x109/L)
- Allergy or intolerance to meropenem or piperacillin-tazobactam.
- Febrile Neutropenia
- Cystic Fibrosis
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fraser Healthlead
- Vancouver Foundationcollaborator
MeSH Terms
Conditions
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
Study Record Dates
First Submitted
February 1, 2010
First Posted
February 10, 2010
Study Start
February 1, 2010
Primary Completion
May 1, 2010
Study Completion
June 1, 2010
Last Updated
August 18, 2010
Record last verified: 2010-01