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Antimicrobial De-escalation Strategy in Medical Patients

Information source: Fraser Health
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Infections

Intervention: Antimicrobial de-escalation strategy (Other)

Phase: N/A

Status: Active, not recruiting

Sponsored by: Fraser Health

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.

Clinical Details

Official title: Antimicrobial De-escalation Strategy in Medical Patients

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

Primary outcome: Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team.

Secondary outcome:

Clinical efficacy (clinical improvement or complete resolution of infection)

Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation

Cost and consumption (usage data) of antibiotics

All cause mortality

Length of stay in the hospital

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.

Eligibility

Minimum age: 19 Years. Maximum age: N/A. Gender(s): Both.

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

Locations and Contacts

Additional Information

Starting date: February 2010
Last updated: August 17, 2010

Page last updated: August 23, 2015

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