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

National University Health System (NUHS)

Status and phase: Unknown; Phase 3; Phase 2

Conditions: Catheter-Related Infections

Treatments: Other: Short-course Antibiotics; Device: Catheter Change

Study type: Interventional

Funder types: Other

Identifiers

NCT02650518

2014/00589

Details and patient eligibility

About

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.

Enrollment: 500 estimated patients

Sex: All

Ages: 21+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Inpatients ≥ 21 years old.
2. Presence of indwelling urinary catheter at the time of urine culture for ≥2days.
3. Fever >38°C.
4. A urine specimen sent to the hospital microbiological laboratory for culture.
5. An antibiotic order for presumed symptomatic catheter associated urinary tract infection.

Exclusion criteria

1. Persistent fever >38°C for more than 24 hours, or any fever >38.9°C.

2. 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

3. 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

4. New requirement for oxygen supplement.

5. Current admission to a high dependency unit or ICU.

6. Radiological evidence of an upper urinary tract infection

7. Flank pain or tenderness, suggesting an upper urinary tract infection

8. Urologic surgical procedure within the previous 72 hours

9. Known structural genitourinary abnormalities including:

   • Nephrostomy tubes
   • Tumours of the urinary tract
   • Ureteric stenting
   • Ureteric strictures
   • Urolithiasis

10. Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract.

11. Received antibiotics for more than 48 hours prior to randomization.

12. Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation.

13. Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate.

14. Pregnancy.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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500 participants in 2 patient groups

Control

No Intervention group

Description:

Subject receives the standard of care that is provided by the primary team taking up his/her case.

Catheter change+Short-course Antibiotics

Experimental group

Treatment:

Device: Catheter Change

Other: Short-course Antibiotics