Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections

Study Overview
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Brief Summary
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Hypothesis: A short course (3-5 days) of antibiotic therapy (experimental arm) is as safe and effective as a long course of antibiotic therapy for the treatment of catheter-associated urinary tract infections.

Official Title
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Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections (CARCUTI)

Conditions
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Catheter-Related Infections

Intervention / Treatment
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* Other: Short-course Antibiotics
* Device: Catheter Change


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inpatients ≥ 21 years old. Presence of indwelling urinary catheter at the time of urine culture for ≥2days. Fever >38°C. A urine specimen sent to the hospital microbiological laboratory for culture. An antibiotic order for presumed symptomatic catheter associated urinary tract infection. Exclusion Criteria: Persistent fever >38°C for more than 24 hours, or any fever >38.9°C. Haemodynamic instability, defined as: Requirement for intravenous vasopressor agents Systolic blood pressure <90 mmHg Acute hypotensive event with drop in systolic blood pressure of >30 mmHg or diastolic blood pressure of >20 mmHg The following laboratory values within the previous 48 hours (if available): White blood cell count>15 or <4 x10^9/L. Procalcitonin>0.25ug/mL C Reactive Protein >100mg/mL An increase in the serum creatinine of more than 50% from baseline New requirement for oxygen supplement. Current admission to a high dependency unit or ICU. Radiological evidence of an upper urinary tract infection Flank pain or tenderness, suggesting an upper urinary tract infection Urologic surgical procedure within the previous 72 hours Known structural genitourinary abnormalities including: Nephrostomy tubes Tumours of the urinary tract Ureteric stenting Ureteric strictures Urolithiasis Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract. Received antibiotics for more than 48 hours prior to randomization. Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation. Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate. Pregnancy.

Ages Eligible for Study
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Minimum Age: 21 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: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control<br>Subject receives the standard of care that is provided by the primary team taking up his/her case. | |
| Experimental: Catheter change+Short-course Antibiotics<br> | Other: Short-course Antibiotics<br>* 3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.<br>Device: Catheter Change<br>* Urinary catheter change once randomization is complete.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution | Resolution of signs and symptoms of CAUTI | Day 14 post-randomisation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Short-Term Resolution | Resolution of signs and symptoms of CAUTI | day 3 and day 7 post-randomisation | 
| Recurrence of fever or symptoms |  | 7, 14 and 30 days post randomization | 
| Haemodynamic instability |  | day 14 post randomization | 
| Admission to high dependency or intensive care units |  | 14 days post-randomization | 
| Length of hospitalization |  | 30 days post-randomization | 
| Re-admission |  | Day 30 post-randomization | 
| Secondary Infections |  | 3 months post-randomization | 
| Recurrent Urinary Tract Infections |  | 3 months and 1 year post-randomization | 
| Urologic surgery or procedure |  | 1 year post-randomization | 
| Antimicrobial use and duration |  | 1 month post-randomization | 
| Colonization or infection by antibiotic-resistant organisms |  | 30 days post-randomization | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Catheter-Associated Urinary Tract Infections, Antimicrobial Stewardship, Short-Course Antimicrobials