Overview

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

Status:
Withdrawn
Trial end date:
2014-01-01
Target enrollment:
0
Participant gender:
All
Summary
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.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
St. Michael's Hospital, Toronto
Unity Health Toronto
Collaborators:
Kingston General Hospital
Kingston Health Sciences Centre
Mount Sinai Hospital, New York
Sunnybrook Health Sciences Centre
The Ottawa Hospital
Treatments:
Anti-Bacterial Agents
Anti-Infective Agents
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)