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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| standard care | No Intervention | Abx will be determined by the managing physician | |
| experimental arm | Experimental | Abx determined by normalization of PCT and basic clinical parameters |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| PCT and clinical algorithm for stopping abx | Other | 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). |
| Measure | Description | Time Frame |
|---|---|---|
| Antibiotic- free days and alive at 14 days after ICU admission | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| mortality at 28 days | 28 days | |
| mortality at 90 days | 90 days | |
| ventilator days at 28 days |
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Inclusion Criteria:
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;
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.
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| Name | Affiliation | Role |
|---|---|---|
| Steven Reynolds, MD | University of British Columbia | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Royal Columbian Hospital | New Westminster | British Columbia | V3L 3W7 | Canada |
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| ID | Term |
|---|---|
| D007239 | Infections |
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|
| 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 |