PCT and Clinical Algorithm for Determination of Duration of Antibiotics

Phase 3

Completed

• Conditions: Infection
• Interventions: Other: PCT and clinical algorithm for stopping abx

• Registration Number: NCT01572831
• Lead Sponsor: Fraser Health

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2012-04
• Study First Submitted: 2012-04-04
• Study First Submitted QC: 2012-04-05
• Study First Posted: 2012-04-06
• Study Start: 2012-05
• Primary Completion: 2013-09
• Study Completion: 2013-09
• Last Update Submitted: 2015-05-22
• Last Update Posted: 2015-05-25

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
experimental arm	PCT and clinical algorithm for stopping abx	Abx determined by normalization of PCT and basic clinical parameters

Primary Outcome Measures

Name	Time	Method
Antibiotic- free days and alive at 14 days after ICU admission	14 days

Secondary Outcome Measures

Name	Time	Method
rates of CDAD	30 days
mortality at 90 days	90 days
colonization/infection with VRE/MRSA over next 30 days	30 days
mortality at 28 days	28 days
ventilator days at 28 days	28 days
relapsed infection	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

Trial Locations

Locations (1)

Royal Columbian Hospital; 🇨🇦 New Westminster, British Columbia, Canada