Antimicrobial De-escalation Strategy in Medical Patients

Fraser Health

Status: Unknown

Conditions: Infections

Treatments: Other: Antimicrobial de-escalation strategy

Study type: Interventional

Funder types: Other

Identifiers

NCT01066013

FHREB 2009-093

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 19+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

100 participants in 2 patient groups

Prospective Antimicrobial de-escalation arm

Experimental group

Description:

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).

Treatment:

Other: Antimicrobial de-escalation strategy

Restrospective control arm

No Intervention group

Description:

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.