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Antimicrobial De-escalation Strategy in Medical Patients

Antimicrobial De-escalation Strategy in Medical Patients

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01066013
Enrollment
100
Registered
2010-02-10
Start date
2010-02-28
Completion date
2010-06-30
Last updated
2010-08-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Infections

Keywords

Antimicrobial De escalation, Meropenem, Piperacillin tazobactam, Medical patients, Appropriate use, Cost savings, Antimicrobial De-escalation strategy

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.

Interventions

OTHERAntimicrobial 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.

Sponsors

Vancouver Foundation
CollaboratorOTHER
Fraser Health
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.7 days

Secondary

MeasureTime frame
Clinical efficacy (clinical improvement or complete resolution of infection)7 days
Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation7 days
Cost and consumption (usage data) of antibiotics7 days
All cause mortality14 days
Length of stay in the hospital14 days

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026