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This study has been withdrawn prior to enrollment.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

November 20, 2008
February 29, 2012
January 2012
January 2014   (final data collection date for primary outcome measure)
  • 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 ]
  • Number of patients enrolled [ Time Frame: 18 months ] [ Designated as safety issue: No ]
  • Protocol Ahderence Rate [ Time Frame: 18 months ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00795470 on ClinicalTrials.gov Archive Site
  • 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 ]
Same as current
Not Provided
Not Provided
 
Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter-associated Urinary Tract Infections in the Critically Ill
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

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.

Not Provided
Interventional
Phase 3
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Urinary Tract Infections
  • Drug: Antimicrobial
    Appropriate antimicrobial based on urine culture results
  • Device: Catheter change
    Change urine catheter
  • 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
    Interventions:
    • Drug: Antimicrobial
    • Device: Catheter change
  • Active Comparator: Catheter change and NO antimicrobial
    Intervention: Device: Catheter change
  • Active Comparator: Antimicrobial and NO catheter change
    Intervention: Drug: Antimicrobial
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Withdrawn
0
Not Provided
January 2014   (final data collection date for primary outcome measure)

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)
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
Canada
 
NCT00795470
REB 08-287
Yes
Dr Jan Friedrich, St. Michael's Hospital
St. Michael's Hospital, Toronto
  • Kingston General Hospital
  • Mount Sinai Hospital, New York
  • The Ottawa Hospital
  • Sunnybrook Health Sciences Centre
Principal Investigator: Jan Friedrich, DPhil, MD, MSc St. Michael's Hospital, Toronto
St. Michael's Hospital, Toronto
February 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP