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PCT and Clinical Algorithm for Determination of Duration of Antibiotics

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ClinicalTrials.gov Identifier: NCT01572831
Recruitment Status : Completed
First Posted : April 6, 2012
Last Update Posted : May 25, 2015
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment Phase
Infection Other: PCT and clinical algorithm for stopping abx Phase 3

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Quadruple (Participant, Care Provider, 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
Study Start Date : May 2012
Primary Completion Date : September 2013
Study Completion Date : September 2013

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Antibiotics
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
No Intervention: standard care
Abx will be determined by the managing physician
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).


Outcome Measures

Primary Outcome Measures :
  1. Antibiotic- free days and alive at 14 days after ICU admission [ Time Frame: 14 days ]

Secondary Outcome Measures :
  1. mortality at 28 days [ Time Frame: 28 days ]
  2. mortality at 90 days [ Time Frame: 90 days ]
  3. ventilator days at 28 days [ Time Frame: 28 days ]
  4. ICU free days at 28 days [ Time Frame: 28 days ]
  5. relapsed infection [ Time Frame: 30 days ]
  6. rates of CDAD [ Time Frame: 30 days ]
  7. colonization/infection with VRE/MRSA over next 30 days [ Time Frame: 30 days ]
  8. duration of abx in control arm for those with and without formal stewardship programs [ Time Frame: 14 days ]

Eligibility Criteria

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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

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To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01572831


Locations
Canada, British Columbia
Royal Columbian Hospital
New Westminster, British Columbia, Canada, V3L 3W7
Sponsors and Collaborators
Fraser Health
Investigators
Principal Investigator: Steven Reynolds, MD University of British Columbia
More Information

Responsible Party: Fraser Health
ClinicalTrials.gov Identifier: NCT01572831     History of Changes
Other Study ID Numbers: FHREB 2011-089
First Posted: April 6, 2012    Key Record Dates
Last Update Posted: May 25, 2015
Last Verified: April 2012

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

Additional relevant MeSH terms:
Anti-Bacterial Agents
Antibiotics, Antitubercular
Calcitonin
Anti-Infective Agents
Antitubercular Agents
Bone Density Conservation Agents
Physiological Effects of Drugs