PCT and Clinical Algorithm for Determination of Duration of Antibiotics
A Pilot Study to Evaluate a Procalcitonin-Based Algorithm for Duration of Antibiotic Therapy in Critically Ill Patients
1 other identifier
interventional
1
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_3
Started May 2012
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 4, 2012
CompletedFirst Posted
Study publicly available on registry
April 6, 2012
CompletedStudy Start
First participant enrolled
May 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2013
CompletedMay 25, 2015
April 1, 2012
1.3 years
April 4, 2012
May 22, 2015
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Antibiotic- free days and alive at 14 days after ICU admission
14 days
Secondary Outcomes (8)
mortality at 28 days
28 days
mortality at 90 days
90 days
ventilator days at 28 days
28 days
ICU free days at 28 days
28 days
relapsed infection
30 days
- +3 more secondary outcomes
Study Arms (2)
standard care
NO INTERVENTIONAbx will be determined by the managing physician
experimental arm
EXPERIMENTALAbx determined by normalization of PCT and basic clinical parameters
Interventions
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).
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Fraser Healthlead
Study Sites (1)
Royal Columbian Hospital
New Westminster, British Columbia, V3L 3W7, Canada
MeSH Terms
Conditions
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Reynolds, MD
University of British Columbia
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 4, 2012
First Posted
April 6, 2012
Study Start
May 1, 2012
Primary Completion
September 1, 2013
Study Completion
September 1, 2013
Last Updated
May 25, 2015
Record last verified: 2012-04