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

History of Changes

Tracking Information
First Received Date ^ICMJE	February 1, 2010
Last Updated Date	August 17, 2010
Start Date ^ICMJE	February 2010
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: February 8, 2010)	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 ]
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01066013 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: February 8, 2010)	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 ]
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Antimicrobial De-escalation Strategy in Medical Patients
Official Title ^ICMJE	Antimicrobial De-escalation Strategy in Medical Patients
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.
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Condition ^ICMJE	Infections
Intervention ^ICMJE	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.
Study Arm (s)	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). Intervention: Other: Antimicrobial de-escalation strategy 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.
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	100
Estimated Completion Date	June 2010
Estimated Primary Completion Date	May 2010 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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
Gender	Both
Ages	19 Years and older
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Not Provided

Administrative Information
NCT Number ^ICMJE	NCT01066013
Other Study ID Numbers ^ICMJE	FHREB 2009-093
Has Data Monitoring Committee	No
Responsible Party	Anisha Lakhani, Fraser Health Authority
Study Sponsor ^ICMJE	Fraser Health
Collaborators ^ICMJE	Vancouver Foundation
Investigators ^ICMJE	Not Provided
Information Provided By	Fraser Health
Verification Date	January 2010
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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