CClinicalTrials.gg
Status unknownNCT01066013Updated Aug 18, 2010

Antimicrobial De-escalation Strategy in Medical Patients

An interventional study of Antimicrobial de-escalation strategy in Infections, sponsored by Fraser Health. Status unknown. Open to participants aged 19 Years and older. Per ClinicalTrials.gov, last updated 2010-08-18.

Sponsored by Fraser Health · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Jan 2010), so the status shown — last known as Active, not recruiting — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
100
Allocation
Non-randomized
Ages
19 Years and older
Sex
All
01

Study 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.

Read the 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.

02

Conditions studied

  • Infections

Keywords

  • Antimicrobial De escalation
  • Meropenem
  • Piperacillin tazobactam
  • Medical patients
  • Appropriate use
  • Cost savings
  • Antimicrobial De-escalation strategy
03

In context

Lead sponsor

Fraser Health is the lead sponsor of 36 studies on the registry; 3 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
19 Years and older
Sexes eligible
All
Accepts 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

Exclusion Criteria:

  • Age less than 19 years
  • Granulocytopenia (\< 1x109/L)
  • Allergy or intolerance to meropenem or piperacillin-tazobactam.
  • Febrile Neutropenia
  • Cystic Fibrosis
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
100 participants (estimated)

Study arms

  • 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).

    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.

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.

06

What researchers measure

Primary outcomes

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

    Time frame: 7 days

Secondary outcomes

  1. Clinical efficacy (clinical improvement or complete resolution of infection)

    Time frame: 7 days

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

    Time frame: 7 days

  3. Cost and consumption (usage data) of antibiotics

    Time frame: 7 days

  4. All cause mortality

    Time frame: 14 days

  5. Length of stay in the hospital

    Time frame: 14 days

07

Study locations

No study locations are listed for this record.

08

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Aug 18, 2010, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT01066013
Lead sponsor
Fraser Health
Collaborators
Vancouver Foundation
First posted
Feb 10, 2010
Start date
Feb 2010
Primary completion
May 2010 (estimated)
Completion
Jun 2010 (estimated)
Last update
Aug 18, 2010

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Jan 2010. You cannot join it, but the record below documents what was studied.

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