PCT and Clinical Algorithm for Determination of Duration of Antibiotics

Study Overview
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Brief Summary
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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.

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

Conditions
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Infection

Intervention / Treatment
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* Other: PCT and clinical algorithm for stopping abx


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 19 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: standard care<br>Abx will be determined by the managing physician | |
| Experimental: experimental arm<br>Abx determined by normalization of PCT and basic clinical parameters | Other: PCT and clinical algorithm for stopping abx<br>* 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).<br>|

What is the study measuring?
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Primary Outcome Measures

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

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| rates of CDAD |  | 30 days | 
| colonization/infection with VRE/MRSA over next 30 days |  | 30 days | 
| duration of abx in control arm for those with and without formal stewardship programs |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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antibiotic cessation rules, procalcitonin, infection, critical care