PCT and Clinical Algorithm for Determination of Duration of Antibiotics

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by Fraser Health.
Recruitment status was  Not yet recruiting
Sponsor:
Information provided by (Responsible Party):
Fraser Health
ClinicalTrials.gov Identifier:
NCT01572831
First received: April 4, 2012
Last updated: April 5, 2012
Last verified: April 2012
  Purpose

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.


Condition Intervention Phase
Infection
Other: PCT and clinical algorithm for stopping abx
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Pilot Study to Evaluate a Procalcitonin-Based Algorithm for Duration of Antibiotic Therapy in Critically Ill Patients

Resource links provided by NLM:


Further study details as provided by Fraser Health:

Primary Outcome Measures:
  • Antibiotic- free days and alive at 14 days after ICU admission [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • mortality at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: Yes ]
  • mortality at 90 days [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • ventilator days at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • ICU free days at 28 days [ Time Frame: 28 days ] [ Designated as safety issue: No ]
  • relapsed infection [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • rates of CDAD [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • colonization/infection with VRE/MRSA over next 30 days [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • duration of abx in control arm for those with and without formal stewardship programs [ Time Frame: 14 days ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: May 2012
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: standard care
Abx will be determined by the managing physician
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).
Experimental: experimental arm
Abx determined by normalization of PCT and basic clinical parameters
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).

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01572831

Contacts
Contact: Steven Reynolds, MD sreynolds.md@gmail.com

Locations
Canada, British Columbia
Royal Columbian Hospital Not yet recruiting
New Westminster, British Columbia, Canada, V3L 3W7
Principal Investigator: Steven Reynolds, MD         
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Steven Reynolds, MD University of British Columbia
  More Information

No publications provided

Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT01572831     History of Changes
Other Study ID Numbers: FHREB 2011-089
Study First Received: April 4, 2012
Last Updated: April 5, 2012
Health Authority: Canada: Health Canada

Keywords provided by Fraser Health:
antibiotic cessation rules
procalcitonin
infection
critical care

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions
Antitubercular Agents

ClinicalTrials.gov processed this record on July 20, 2014