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

Study Overview
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Brief Summary
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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.

Official Title
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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

Conditions
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Urinary Tract Infections

Intervention / Treatment
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* Drug: Antimicrobial
* Device: Catheter change


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: No catheter change no antimicrobial<br>Urinary catheter will not be changed and no antimicrobials will be prescribed | |
| Active Comparator: Antimicrobial and catheter change<br> | Drug: Antimicrobial<br>* Appropriate antimicrobial based on urine culture results<br>Device: Catheter change<br>* Change urine catheter<br>|
| Active Comparator: Catheter change and NO antimicrobial<br> | Device: Catheter change<br>* Change urine catheter<br>|
| Active Comparator: Antimicrobial and NO catheter change<br> | Drug: Antimicrobial<br>* Appropriate antimicrobial based on urine culture results<br>|

What is the study measuring?
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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 | Measure Description | Time Frame |
| --- | --- | --- |
| ICU free days at Day 30 |  | 30 days | 
| Microbiologic Outcome |  | Day 7 and 14 | 
| Developement of resistance |  | 14 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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urinary tract infection, critically ill, ICU, antimicrobial, Catheter associated urinary tract infections