Antimicrobial De-escalation Strategy in Medical Patients
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|ClinicalTrials.gov 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
|Condition or disease||Intervention/treatment||Phase|
|Infections||Other: Antimicrobial de-escalation strategy||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Antimicrobial De-escalation Strategy in Medical Patients|
|Study Start Date :||February 2010|
|Estimated Primary Completion Date :||May 2010|
|Estimated Study Completion Date :||June 2010|
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.
- Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team. [ Time Frame: 7 days ]
- 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 ]