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

Fraser Health1 site in 1 country1 target enrollmentMay 2012

ConditionsInfection

Overview

Phase: Phase 3
Intervention: Not specified
Conditions: Infection
Sponsor: Fraser Health
Enrollment: 1
Locations: 1
Primary Endpoint: Antibiotic- free days and alive at 14 days after ICU admission
Status: Completed
Last Updated: 10 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

May 2012

End Date

September 2013

Last Updated

10 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Fraser Health

Responsible Party

Sponsor

Eligibility Criteria

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.

Outcomes

Primary Outcomes

Antibiotic- free days and alive at 14 days after ICU admission

Time Frame: 14 days

Secondary Outcomes

mortality at 28 days(28 days)
colonization/infection with VRE/MRSA over next 30 days(30 days)
mortality at 90 days(90 days)
ventilator days at 28 days(28 days)
relapsed infection(30 days)
rates of CDAD(30 days)
ICU free days at 28 days(28 days)
duration of abx in control arm for those with and without formal stewardship programs(14 days)