Antimicrobial De-escalation Strategy in Medical Patients
The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2010 by Fraser Health.
Recruitment status was Active, not recruiting
Recruitment status was Active, not recruiting
Sponsor:
Fraser Health
Collaborator:
Vancouver Foundation
Information provided by:
Fraser Health
ClinicalTrials.gov Identifier:
NCT01066013
First received: February 1, 2010
Last updated: August 17, 2010
Last verified: January 2010
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Infections |
Other: Antimicrobial de-escalation strategy |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | Antimicrobial De-escalation Strategy in Medical Patients |
Resource links provided by NLM:
Further study details as provided by Fraser Health:
Primary Outcome Measures:
- Number of patients who had therapy with meropenem or piperacillin/tazobactam de-escalated by the de-escalation team. [ Time Frame: 7 days ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Clinical efficacy (clinical improvement or complete resolution of infection) [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Appropriateness of broadspectrum antibiotic (meropenem or piperacillin/tazobactam) prior to de-escalation [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- Cost and consumption (usage data) of antibiotics [ Time Frame: 7 days ] [ Designated as safety issue: No ]
- All cause mortality [ Time Frame: 14 days ] [ Designated as safety issue: No ]
- Length of stay in the hospital [ Time Frame: 14 days ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 100 |
| Study Start Date: | February 2010 |
| Estimated Study Completion Date: | June 2010 |
| Estimated Primary Completion Date: | May 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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
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.
|
|
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.
|
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| Ages Eligible for Study: | 19 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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
Contacts and Locations
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To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below.
For general information, see Learn About Clinical Studies.
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More Information
No publications provided
| Responsible Party: | Anisha Lakhani, Fraser Health Authority |
| ClinicalTrials.gov Identifier: | NCT01066013 History of Changes |
| Other Study ID Numbers: | FHREB 2009-093 |
| Study First Received: | February 1, 2010 |
| Last Updated: | August 17, 2010 |
| Health Authority: | Canada: Ethics Review Committee |
Keywords provided by Fraser Health:
|
Antimicrobial De escalation Meropenem Piperacillin tazobactam Medical patients |
Appropriate use Cost savings Antimicrobial De-escalation strategy |
Additional relevant MeSH terms:
|
Anti-Infective Agents Pharmacologic Actions Therapeutic Uses |
ClinicalTrials.gov processed this record on February 25, 2015