Back to resultsPCT and Clinical Algorithm for Determination of Duration of Antibiotics
Primary Purpose
Infection
Status
Completed
Phase
Phase 3
Locations
Canada
Study Type
Interventional
Intervention
PCT and clinical algorithm for stopping abx
Sponsored by
About this trial
This is an interventional treatment trial for Infection focused on measuring antibiotic cessation rules, procalcitonin, infection, critical care
Eligibility Criteria
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.
Sites / Locations
- Royal Columbian Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
standard care
experimental arm
Arm Description
Abx will be determined by the managing physician
Abx determined by normalization of PCT and basic clinical parameters
Outcomes
Primary Outcome Measures
Antibiotic- free days and alive at 14 days after ICU admission
Secondary Outcome Measures
mortality at 28 days
mortality at 90 days
ventilator days at 28 days
ICU free days at 28 days
relapsed infection
rates of CDAD
colonization/infection with VRE/MRSA over next 30 days
duration of abx in control arm for those with and without formal stewardship programs
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01572831
Brief Title
PCT and Clinical Algorithm for Determination of Duration of Antibiotics
Official Title
A Pilot Study to Evaluate a Procalcitonin-Based Algorithm for Duration of Antibiotic Therapy in Critically Ill Patients
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
May 2012 (undefined)
Primary Completion Date
September 2013 (Actual)
Study Completion Date
September 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Fraser Health
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Infection
Keywords
antibiotic cessation rules, procalcitonin, infection, critical care
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Single Group Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
1 (Actual)
8. Arms, Groups, and Interventions
Arm Title
standard care
Arm Type
No Intervention
Arm Description
Abx will be determined by the managing physician
Arm Title
experimental arm
Arm Type
Experimental
Arm Description
Abx determined by normalization of PCT and basic clinical parameters
Intervention Type
Other
Intervention Name(s)
PCT and clinical algorithm for stopping abx
Intervention Description
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).
Primary Outcome Measure Information:
Title
Antibiotic- free days and alive at 14 days after ICU admission
Time Frame
14 days
Secondary Outcome Measure Information:
Title
mortality at 28 days
Time Frame
28 days
Title
mortality at 90 days
Time Frame
90 days
Title
ventilator days at 28 days
Time Frame
28 days
Title
ICU free days at 28 days
Time Frame
28 days
Title
relapsed infection
Time Frame
30 days
Title
rates of CDAD
Time Frame
30 days
Title
colonization/infection with VRE/MRSA over next 30 days
Time Frame
30 days
Title
duration of abx in control arm for those with and without formal stewardship programs
Time Frame
14 days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Reynolds, MD
Organizational Affiliation
University of British Columbia
Official's Role
Principal Investigator
Facility Information:
Facility Name
Royal Columbian Hospital
City
New Westminster
State/Province
British Columbia
ZIP/Postal Code
V3L 3W7
Country
Canada
12. IPD Sharing Statement
Learn more about this trial
PCT and Clinical Algorithm for Determination of Duration of Antibiotics
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