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

Phase 2

• Conditions: Catheter-Related Infections
• Interventions: Other: Short-course Antibiotics; Device: Catheter Change

• Registration Number: NCT02650518
• Lead Sponsor: National University Hospital, Singapore

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-12
• Study First Submitted: 2015-12-30
• Status Verified: 2016-01
• Study First Submitted QC: 2016-01-07
• Last Update Submitted: 2016-01-07
• Study First Posted: 2016-01-08
• Last Update Posted: 2016-01-08
• Primary Completion: 2017-10
• Study Completion: 2018-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 500

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Catheter change+Short-course Antibiotics	Catheter Change	-
Catheter change+Short-course Antibiotics	Short-course Antibiotics	-

Primary Outcome Measures

Name	Time	Method
Resolution	Day 14 post-randomisation	Resolution of signs and symptoms of CAUTI

Secondary Outcome Measures

Name	Time	Method
Admission to high dependency or intensive care units	14 days 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
Short-Term Resolution	day 3 and day 7 post-randomisation	Resolution of signs and symptoms of CAUTI
Recurrence of fever or symptoms	7, 14 and 30 days post randomization
Haemodynamic instability	day 14 post randomization
Length of hospitalization	30 days post-randomization
Re-admission	Day 30 post-randomization

Trial Locations

Locations (3)

National University Hospital; 🇸🇬 Singapore, Singapore

Tan Tock Seng Hospital; 🇸🇬 Singapore, Singapore

Singapore General Hospital; 🇸🇬 Singapore, Singapore