Antimicrobial De-escalation Strategy in Medical Patients

NCT ID: NCT01066013

Last Updated: 2010-08-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-02-28
• Study Completion Date: 2010-06-30

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.

Conditions

Infections

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

Antimicrobial de-escalation strategy

Intervention Type: OTHER

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.

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.

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

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.

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Vancouver Foundation

OTHER

Sponsor Role: collaborator

Fraser Health

OTHER

Sponsor Role: lead

Responsible Party

Fraser Health Authority

Other Identifiers

FHREB 2009-093

Identifier Type: -

Identifier Source: org_study_id