- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01572831
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
Intervention / Treatment
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
-
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British Columbia
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New Westminster, British Columbia, Canada, V3L 3W7
- Royal Columbian Hospital
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-
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
|
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Experimental: experimental arm
Abx determined by normalization of PCT and basic clinical parameters
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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
Additional Relevant MeSH Terms
Other Study ID Numbers
- FHREB 2011-089
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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Clinical Trials on PCT and clinical algorithm for stopping abx
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Nantes University HospitalUniversity Hospital, Angers; University Hospital, Bordeaux; Poitiers University... and other collaboratorsCompletedEarly-onset Neonatal InfectionFrance
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National Heart, Lung, and Blood Institute (NHLBI)Bristol-Myers SquibbCompletedStroke | Venous Thrombosis | Atrial Fibrillation | Atrial FlutterUnited States
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-
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-
VA Office of Research and DevelopmentMinneapolis Veterans Affairs Medical Center; San Francisco Veterans Affairs... and other collaboratorsCompletedPost-traumatic Stress Disorder | Moral Injury | Traumatic LossUnited States
-
Stanford UniversityActive, not recruiting
-
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