PCT and Clinical Algorithm for Determination of Duration of Antibiotics

NCT ID: NCT01572831

Last Updated: 2015-05-25

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 1 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-31
• Study Completion Date: 2013-09-30

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.

Conditions

Infection

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

standard care

Abx will be determined by the managing physician

Group Type: NO_INTERVENTION

No interventions assigned to this group

experimental arm

Abx determined by normalization of PCT and basic clinical parameters

Group Type: EXPERIMENTAL

PCT and clinical algorithm for stopping abx

Intervention Type: 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).

Interventions

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).

Intervention Type: OTHER

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.

• Minimum Eligible Age: 19 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Fraser Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Steven Reynolds, MD

Role: PRINCIPAL_INVESTIGATOR

University of British Columbia

Locations

Royal Columbian Hospital

New Westminster, British Columbia, Canada

Countries

Canada

Other Identifiers

FHREB 2011-089

Identifier Type: -

Identifier Source: org_study_id