Status:
WITHDRAWN
Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter Urinary Tract Infections.
Lead Sponsor:
Unity Health Toronto
Collaborating Sponsors:
Kingston Health Sciences Centre
Mount Sinai Hospital, New York
Conditions:
Urinary Tract Infections
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Urinary tract infection (UTI) is a common infection in patients in the intensive care unit (ICU) that increases length of stay but not mortality. It is not known whether antibiotic treatment will alte...
Eligibility Criteria
Inclusion
- Adult ICU patient (≥ 18 years old)
- Admitted to the ICU for ≥ 96 hours
- Indwelling urinary catheter in place for ≥ 48hours that was inserted during this hospital admission
- Urine culture positive (≥ 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus)
- Have received antimicrobial therapy that would cover the isolated organism(s) in the index urine culture for \< 24 hours (i.e. therapy that does NOT cover the isolated organism(s) in the index urine culture of any duration or antimicrobial that covers the index urine organism for \< 24 hours are permitted)
Exclusion
- Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture
- Anuria (\< 50 mL/day)
- Imminent death within 48 hours or decision to withdraw supportive care by clinical team
- Neutropenia (\< 500/mm3)
- Patient has an alternative infection and requires an antimicrobial that has a spectrum of activity which include all the organism(s) isolated from the index urine culture
- Mixed fungal/bacterial CAUTI (i.e. index urine culture contains both bacteria and fungus)
Key Trial Info
Start Date :
January 1 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
Patients enrolled
Trial Details
Trial ID
NCT00795470
Start Date
January 1 2012
End Date
January 1 2014
Last Update
December 3 2015
Active Locations (1)
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1
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8