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Sponsors and Collaborators: |
St. Michael's Hospital, Toronto Kingston General Hospital MOUNT SINAI HOSPITAL Ottawa General Hospital Sunnybrook Health Sciences Centre |
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Information provided by: | St. Michael's Hospital, Toronto |
ClinicalTrials.gov Identifier: | NCT00795470 |
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 alter outcomes. Our previous studies have documented wide practice variations exist amongst doctors, including prescribing antibiotics to asymptomatic patients. Therefore, the merits of various ways to manage the infection require further studies to minimize the potential for over-prescribing of antibiotics, a practice that can increase the development of resistant bacteria.
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.
Condition | Intervention | Phase |
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Urinary Tract Infections |
Drug: Antimicrobial Device: Catheter change |
Phase III |
Study Type: | Interventional |
Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Factorial Assignment |
Official Title: | A Pilot Concealed Randomized Double-Blinded Placebo-Controlled Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter-Associated Urinary Tract Infections in the Critically Ill |
Estimated Enrollment: | 80 |
Study Start Date: | February 2009 |
Estimated Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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No catheter change no antimicrobial: No Intervention
Urinary catheter will not be changed and no antimicrobials will be prescribed
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Antimicrobial and catheter change: Active Comparator |
Drug: Antimicrobial
Appropriate antimicrobial based on urine culture results
Device: Catheter change
Change urine catheter
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Catheter change and NO antimicrobial: Active Comparator |
Device: Catheter change
Change urine catheter
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Antimicrobial and NO catheter change: Active Comparator |
Drug: Antimicrobial
Appropriate antimicrobial based on urine culture results
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Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contact: Jan O Friedrich, DPhil, MD, MSc | 416-864-6000 |
Canada, Ontario | |
St. Michael's Hospital | |
Toronto, Ontario, Canada, M5B1W8 |
Principal Investigator: | Jan Friedrich, DPhil, MD, MSc | St. Michael's Hospital, Toronto |
Responsible Party: | St. Michael's Hospital ( Dr Jan Friedrich ) |
Study ID Numbers: | REB 08-287 |
Study First Received: | November 20, 2008 |
Last Updated: | December 2, 2008 |
ClinicalTrials.gov Identifier: | NCT00795470 |
Health Authority: | Canada: Health Canada |
urinary tract infection critically ill ICU antimicrobial Catheter associated urinary tract infections |
Urologic Diseases Critical Illness Urinary Tract Infections |
Communicable Diseases Disease Attributes Pathologic Processes Infection |