Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter Urinary Tract Infections.
NCT ID: NCT00795470
Last Updated: 2015-12-03
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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WITHDRAWN
PHASE3
INTERVENTIONAL
2012-01-31
2014-01-31
Brief Summary
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The objective of this pilot study is to determine the feasibility of conducting a larger definitive study that will determine the effect of catheter change and/or systemic antibiotics as compared to no interventions on outcomes and resource utilization in ICU patients with UTI. Patients will be randomized to receive no treatment, antibiotics alone, urine catheter change alone, and both catheter change and antibiotics. Their clinical outcomes will be assessed.
Results from the pilot trial will provide information about whether it is feasible to conduct the larger definitive trial. Results of the definitive study will provide guidance to clinicians on how to manage a frequent clinical problem and optimize antibiotic usage.
Detailed Description
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Conditions
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Study Design
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RANDOMIZED
FACTORIAL
TREATMENT
QUADRUPLE
Study Groups
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No catheter change no antimicrobial
Urinary catheter will not be changed and no antimicrobials will be prescribed
No interventions assigned to this group
Antimicrobial and catheter change
Antimicrobial
Appropriate antimicrobial based on urine culture results
Catheter change
Change urine catheter
Catheter change and NO antimicrobial
Catheter change
Change urine catheter
Antimicrobial and NO catheter change
Antimicrobial
Appropriate antimicrobial based on urine culture results
Interventions
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Antimicrobial
Appropriate antimicrobial based on urine culture results
Catheter change
Change urine catheter
Eligibility Criteria
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Inclusion Criteria
2. Admitted to the ICU for ≥ 96 hours
3. Indwelling urinary catheter in place for ≥ 48hours that was inserted during this hospital admission
4. Urine culture positive (≥ 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus)
5. 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 Criteria
2. Anuria (\< 50 mL/day)
3. Imminent death within 48 hours or decision to withdraw supportive care by clinical team
4. Neutropenia (\< 500/mm3)
5. 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
6. Mixed fungal/bacterial CAUTI (i.e. index urine culture contains both bacteria and fungus)
18 Years
ALL
No
Sponsors
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Kingston Health Sciences Centre
OTHER
Mount Sinai Hospital, New York
OTHER
The Ottawa Hospital
OTHER
Sunnybrook Health Sciences Centre
OTHER
Unity Health Toronto
OTHER
Responsible Party
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Principal Investigators
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Jan Friedrich, DPhil, MD, MSc
Role: PRINCIPAL_INVESTIGATOR
Unity Health Toronto
Locations
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St. Michael's Hospital
Toronto, Ontario, Canada
Countries
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References
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Chant C, Dos Santos CC, Saccucci P, Smith OM, Marshall JC, Friedrich JO. Discordance between perception and treatment practices associated with intensive care unit-acquired bacteriuria and funguria: a Canadian physician survey. Crit Care Med. 2008 Apr;36(4):1158-67. doi: 10.1097/CCM.0b013e3181692af9.
Other Identifiers
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REB 08-287
Identifier Type: -
Identifier Source: org_study_id