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

Primary Purpose

Urinary Tract Infections

Status

Withdrawn

Phase

Phase 3

Locations

Canada

Study Type

Interventional

Intervention

Antimicrobial

Catheter change

About this trial

This is an interventional treatment trial for Urinary Tract Infections focused on measuring urinary tract infection, critically ill, ICU, antimicrobial, Catheter associated urinary tract infections

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Adult ICU patient (≥ 18 years old)
Admitted to the ICU for ≥ 96 hours
Indwelling urinary catheter in place for ≥ 48hours that was inserted during this hospital admission
Urine culture positive (≥ 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus)
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:

Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture
Anuria (< 50 mL/day)
Imminent death within 48 hours or decision to withdraw supportive care by clinical team
Neutropenia (< 500/mm3)
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
Mixed fungal/bacterial CAUTI (i.e. index urine culture contains both bacteria and fungus)

Sites / Locations

St. Michael's Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

Active Comparator

Arm Label

No catheter change no antimicrobial

Antimicrobial and catheter change

Catheter change and NO antimicrobial

Antimicrobial and NO catheter change

Arm Description

Urinary catheter will not be changed and no antimicrobials will be prescribed

Outcomes

Primary Outcome Measures

Number of patients enrolled

none enrolled

Protocol Adherence Rate

Secondary Outcome Measures

ICU free days at Day 30

Microbiologic Outcome

Developement of resistance

Full Information

NCT ID

NCT00795470

First Posted

November 20, 2008

Last Updated

December 1, 2015

Sponsor

Unity Health Toronto

Collaborators

Queen's University, Mount Sinai Hospital, New York, The Ottawa Hospital, Sunnybrook Health Sciences Centre

1. Study Identification

Unique Protocol Identification Number

NCT00795470

Brief Title

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

Acronym

CAUTION

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2015

Overall Recruitment Status

Withdrawn

Why Stopped

Not pursuing the study due to funding issues

Study Start Date

January 2012 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Unity Health Toronto

Collaborators

Queen's University, Mount Sinai Hospital, New York, The Ottawa Hospital, Sunnybrook Health Sciences Centre

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Urinary Tract Infections

Keywords

urinary tract infection, critically ill, ICU, antimicrobial, Catheter associated urinary tract infections

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 3

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigatorOutcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

No catheter change no antimicrobial

Arm Type

No Intervention

Arm Description

Urinary catheter will not be changed and no antimicrobials will be prescribed

Arm Title

Antimicrobial and catheter change

Arm Type

Active Comparator

Arm Title

Catheter change and NO antimicrobial

Arm Type

Active Comparator

Arm Title

Antimicrobial and NO catheter change

Arm Type

Active Comparator

Intervention Type

Drug

Intervention Name(s)

Antimicrobial

Intervention Description

Appropriate antimicrobial based on urine culture results

Intervention Type

Device

Intervention Name(s)

Catheter change

Intervention Description

Change urine catheter

Primary Outcome Measure Information:

Title

Number of patients enrolled

Description

none enrolled

Time Frame

18 months

Title

Protocol Adherence Rate

Time Frame

18 months

Secondary Outcome Measure Information:

Title

ICU free days at Day 30

Time Frame

30 days

Title

Microbiologic Outcome

Time Frame

Day 7 and 14

Title

Developement of resistance

Time Frame

14 days

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Adult ICU patient (≥ 18 years old) Admitted to the ICU for ≥ 96 hours Indwelling urinary catheter in place for ≥ 48hours that was inserted during this hospital admission Urine culture positive (≥ 105 CFU/mL) for 1 or 2 organism (s) (e.g. bacteria or fungus) 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: Suspected or confirmed pyelonephritis, renal abscess, or concurrent bacteremia with the same organism(s) as those isolated in the index urine culture Anuria (< 50 mL/day) Imminent death within 48 hours or decision to withdraw supportive care by clinical team Neutropenia (< 500/mm3) 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 Mixed fungal/bacterial CAUTI (i.e. index urine culture contains both bacteria and fungus)

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jan Friedrich, DPhil, MD, MSc

Organizational Affiliation

Unity Health Toronto

Official's Role

Principal Investigator

Facility Information:

Facility Name

St. Michael's Hospital

City

Toronto

State/Province

Ontario

ZIP/Postal Code

M5B1W8

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

18379242

Citation

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.

Results Reference

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

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