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Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter-associated Urinary Tract Infections in the Critically Ill (CAUTION)

This study has been withdrawn prior to enrollment.
(Not pursuing the study due to funding issues)
Sponsor:
Collaborators:
Kingston General Hospital
Mount Sinai Hospital, New York
The Ottawa Hospital
Sunnybrook Health Sciences Centre
Information provided by:
St. Michael's Hospital, Toronto
ClinicalTrials.gov Identifier:
NCT00795470
First received: November 20, 2008
Last updated: February 29, 2012
Last verified: February 2012
History of Changes
  Purpose

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
Urinary Tract Infections
 Drug: Antimicrobial
Device: Catheter change
 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by St. Michael's Hospital, Toronto:

Primary Outcome Measures:
  • Number of patients enrolled [ Time Frame: 18 months ] [ Designated as safety issue: No ]
    none enrolled

  • Protocol Adherence Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • ICU free days at Day 30 [ Time Frame: 30 days ] [ Designated as safety issue: No ]
  • Microbiologic Outcome [ Time Frame: Day 7 and 14 ] [ Designated as safety issue: No ]
  • Developement of resistance [ Time Frame: 14 days ] [ Designated as safety issue: Yes ]

Enrollment: 0
Study Start Date: January 2012
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: No catheter change no antimicrobial
Urinary catheter will not be changed and no antimicrobials will be prescribed
Active Comparator: Antimicrobial and catheter change Drug: Antimicrobial
Appropriate antimicrobial based on urine culture results
Device: Catheter change
Change urine catheter
Active Comparator: Catheter change and NO antimicrobial Device: Catheter change
Change urine catheter
Active Comparator: Antimicrobial and NO catheter change Drug: Antimicrobial
Appropriate antimicrobial based on urine culture results

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Adult ICU patient (≥ 18 years old)
  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:

  1. Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture
  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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00795470

Locations
Canada, Ontario
St. Michael's Hospital
Toronto, Ontario, Canada, M5B1W8
Sponsors and Collaborators
St. Michael's Hospital, Toronto
Kingston General Hospital
Mount Sinai Hospital, New York
The Ottawa Hospital
Sunnybrook Health Sciences Centre
Investigators
Principal Investigator: Jan Friedrich, DPhil, MD, MSc St. Michael's Hospital, Toronto
  More Information

Publications:

Responsible Party: Dr Jan Friedrich, St. Michael's Hospital
ClinicalTrials.gov Identifier: NCT00795470     History of Changes
Other Study ID Numbers: REB 08-287
Study First Received: November 20, 2008
Last Updated: February 29, 2012
Health Authority: Canada: Health Canada

Keywords provided by St. Michael's Hospital, Toronto:
urinary tract infection
critically ill
ICU
antimicrobial
Catheter associated urinary tract infections

Additional relevant MeSH terms:
Critical Illness
Urinary Tract Infections
Disease Attributes
Pathologic Processes
Infection
 Urologic Diseases
Anti-Infective Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013