Factorial Trial of Antimicrobial Therapy and/or Catheter Change for Catheter Urinary Tract Infections. (CAUTION)

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.

Study Overview

• Status: Withdrawn
• Conditions: Urinary Tract Infections
• Intervention / Treatment: Drug: Antimicrobial; Device: Catheter change

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Toronto, Ontario, Canada, M5B1W8
      • St. Michael's Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Factorial Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of patients enrolled	none enrolled	18 months
Protocol Adherence Rate		18 months

Secondary Outcome Measures

Outcome Measure	Time Frame
ICU free days at Day 30	30 days
Microbiologic Outcome	Day 7 and 14
Developement of resistance	14 days

Collaborators and Investigators

• Sponsor: Unity Health Toronto
• Collaborators: Sunnybrook Health Sciences Centre; The Ottawa Hospital; Queen's University; Mount Sinai Hospital, New York
• Investigators: Principal Investigator: Jan Friedrich, DPhil, MD, MSc, Unity Health Toronto

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2012
• Primary Completion (Actual): January 1, 2014
• Study Completion (Actual): January 1, 2014

Study Registration Dates

• First Submitted: November 20, 2008
• First Submitted That Met QC Criteria: November 20, 2008
• First Posted (Estimate): November 21, 2008

Study Record Updates

• Last Update Posted (Estimate): December 3, 2015
• Last Update Submitted That Met QC Criteria: December 1, 2015
• Last Verified: November 1, 2015

More Information

Terms related to this study

• Keywords: ICU; critically ill; antimicrobial; urinary tract infection; Catheter associated urinary tract infections
• Additional Relevant MeSH Terms: Pathologic Processes; Urologic Diseases; Disease Attributes; Infections; Communicable Diseases; Urinary Tract Infections; Anti-Bacterial Agents; Anti-Infective Agents
• Other Study ID Numbers: REB 08-287