Catheter-Related Infections
Conditions
Keywords
Catheter-Associated Urinary Tract Infections, Antimicrobial Stewardship, Short-Course Antimicrobials
Brief summary
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.
Interventions
OTHERShort-course Antibiotics
3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.
DEVICECatheter Change
Urinary catheter change once randomization is complete.
Sponsors
Tan Tock Seng Hospital
Singapore General Hospital
National University of Singapore
National University Hospital, Singapore
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Resolution | Day 14 post-randomisation | Resolution of signs and symptoms of CAUTI |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | — |
| Short-Term Resolution | day 3 and day 7 post-randomisation | Resolution of signs and symptoms of CAUTI |
| 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 | — |
| Secondary Infections | 3 months post-randomization | — |
Countries
Singapore
Contacts
Primary ContactPaul A Tambyah, MD
Outcome results
None listed