Antimicrobial De-escalation Strategy in Medical Patients

Infections Clinical Trial

Official title:

Antimicrobial De-escalation Strategy in Medical Patients

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01066013
• Other study ID #: FHREB 2009-093
• Status: Active, not recruiting
• Phase: N/A
• First received: February 1, 2010
• Last updated: August 17, 2010
• Start date: February 2010
• Est. completion date: June 2010

Study information

• Verified date: January 2010
• Source: Fraser Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: June 2010
• Est. primary completion date: May 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Study Design

Allocation: Non-Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infections

Intervention

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.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Fraser Health	Vancouver Foundation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.		7 days	No
Secondary	Clinical efficacy (clinical improvement or complete resolution of infection)		7 days	No
Secondary	Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation		7 days	No
Secondary	Cost and consumption (usage data) of antibiotics		7 days	No
Secondary	All cause mortality		14 days	No
Secondary	Length of stay in the hospital		14 days	No