Infection
Conditions
Keywords
antibiotic cessation rules, procalcitonin, infection, critical care
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.
Interventions
OTHERPCT and clinical algorithm for stopping abx
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).
Sponsors
Fraser Health
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
19 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Antibiotic- free days and alive at 14 days after ICU admission | 14 days |
Secondary
| Measure | Time frame |
|---|---|
| mortality at 90 days | 90 days |
| ventilator days at 28 days | 28 days |
| ICU free days at 28 days | 28 days |
| mortality at 28 days | 28 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 |
| relapsed infection | 30 days |
Countries
Canada
Outcome results
None listed