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

Phase 3

Withdrawn

• Conditions: Urinary Tract Infections
• Interventions: Drug: Antimicrobial; Device: Catheter change

• Registration Number: NCT00795470
• Lead Sponsor: Unity Health Toronto

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2008-11-20
• Study First Submitted QC: 2008-11-20
• Study First Posted: 2008-11-21
• Study Start: 2012-01
• Primary Completion: 2014-01
• Study Completion: 2014-01
• Status Verified: 2015-11
• Last Update Submitted: 2015-12-01
• Last Update Posted: 2015-12-03

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
Antimicrobial and catheter change	Antimicrobial	-
Antimicrobial and catheter change	Catheter change	-
Antimicrobial and NO catheter change	Antimicrobial	-
Catheter change and NO antimicrobial	Catheter change	-

Primary Outcome Measures

Name	Time	Method
Number of patients enrolled	18 months	none enrolled
Protocol Adherence Rate	18 months

Secondary Outcome Measures

Name	Time	Method
Developement of resistance	14 days
ICU free days at Day 30	30 days
Microbiologic Outcome	Day 7 and 14

Trial Locations

Locations (1)

St. Michael's Hospital; 🇨🇦 Toronto, Ontario, Canada