PCT and Clinical Algorithm for Determination of Duration of Antibiotics

May 22, 2015 updated by: Fraser Health

A Pilot Study to Evaluate a Procalcitonin-Based Algorithm for Duration of Antibiotic Therapy in Critically Ill Patients

Patients in the ICU whose infection is resolving will be randomized to standard duration of antibiotics compared to duration determined by a combination of a procalcitonin value and a simple evaluation of clinical status.

Study Overview

Status

Completed

Conditions

Study Type

Interventional

Enrollment (Actual)

1

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • British Columbia
      • New Westminster, British Columbia, Canada, V3L 3W7
        • Royal Columbian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

19 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adult patients (19 years and older) treated with ABx for reasons other than prophylaxis within the last 24 hours and who are admitted to a critical care environment.

Exclusion Criteria:

  • Declined consent
  • Any infection that according to evidence-based guidelines which would usually receive more than 2 weeks of antibiotic therapy including, but not limited to;

    • Infective endocarditis
    • Osteomyelitis
    • Undrained abscess
  • Not expected to survive 48 hours
  • Immunosuppression (HIV positive, any immunosuppressive medications, any steroid dose, neutrophil count less than 1.0)
  • Previously enrolled in this study
  • Presently enrolled in a separate study which is felt by study investigators to have biological or clinical process in conflict with this study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: standard care
Abx will be determined by the managing physician
Experimental: experimental arm
Abx determined by normalization of PCT and basic clinical parameters
In the experimental arm, antibiotics will be stopped based upon the PCT-guided algorithm. This PCT algorithm also incorporates clinical parameters to ensure utmost safety for the patients. These clinical parameters are; resolution of fever (temperature less than 38.3 and greater than 36.0), shock (on no vasopressors), and leukocytosis (<12,000 and >4,000).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antibiotic- free days and alive at 14 days after ICU admission
Time Frame: 14 days
14 days

Secondary Outcome Measures

Outcome Measure
Time Frame
mortality at 28 days
Time Frame: 28 days
28 days
mortality at 90 days
Time Frame: 90 days
90 days
ventilator days at 28 days
Time Frame: 28 days
28 days
ICU free days at 28 days
Time Frame: 28 days
28 days
relapsed infection
Time Frame: 30 days
30 days
rates of CDAD
Time Frame: 30 days
30 days
colonization/infection with VRE/MRSA over next 30 days
Time Frame: 30 days
30 days
duration of abx in control arm for those with and without formal stewardship programs
Time Frame: 14 days
14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Investigators

  • Principal Investigator: Steven Reynolds, MD, University of British Columbia

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2012

Primary Completion (Actual)

September 1, 2013

Study Completion (Actual)

September 1, 2013

Study Registration Dates

First Submitted

April 4, 2012

First Submitted That Met QC Criteria

April 5, 2012

First Posted (Estimate)

April 6, 2012

Study Record Updates

Last Update Posted (Estimate)

May 25, 2015

Last Update Submitted That Met QC Criteria

May 22, 2015

Last Verified

April 1, 2012

More Information

Terms related to this study

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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