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Completed

NCT Number: NCT01572831

PCT and Clinical Algorithm for Determination of Duration of Antibiotics

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.

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Key information

Conditions

Infection Infections

Age range

19 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Royal Columbian Hospital

New Westminster, British Columbia, V3L 3W7, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

PCT and clinical algorithm for stopping abx

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).

Primary outcomes

  1. Antibiotic- free days and alive at 14 days after ICU admission

    Time frame: 14 days

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Fraser Health

Other

Registry information

Official study title

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

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Apr 6, 2012
Registry last updated
May 25, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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