PCT and Clinical Algorithm for Determination of Duration of Antibiotics

Infection Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01572831
• Other study ID #: FHREB 2011-089
• Status: Completed
• Phase: Phase 3
• First received: April 4, 2012
• Last updated: May 22, 2015
• Start date: May 2012
• Est. completion date: September 2013

Study information

• Verified date: April 2012
• Source: Fraser Health
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Health Canada
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1
• Est. completion date: September 2013
• Est. primary completion date: September 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 19 Years and older

Eligibility

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

Allocation: Randomized, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Infection

Intervention

Other:
• PCT 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).

Locations

Country	Name	City	State
Canada	Royal Columbian Hospital	New Westminster	British Columbia

Sponsors (1)

Lead Sponsor	Collaborator
Fraser Health

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Antibiotic- free days and alive at 14 days after ICU admission		14 days	No
Secondary	mortality at 28 days		28 days	Yes
Secondary	mortality at 90 days		90 days	Yes
Secondary	ventilator days at 28 days		28 days	No
Secondary	ICU free days at 28 days		28 days	No
Secondary	relapsed infection		30 days	No
Secondary	rates of CDAD		30 days	No
Secondary	colonization/infection with VRE/MRSA over next 30 days		30 days	No
Secondary	duration of abx in control arm for those with and without formal stewardship programs		14 days	No