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

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

Sponsors

Lead sponsor: National University Hospital, Singapore

Collaborator: Tan Tock Seng Hospital
Singapore General Hospital
National University, Singapore

Source 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.

Overall Status Unknown status
Start Date December 2015
Completion Date October 2018
Primary Completion Date October 2017
Phase Phase 2/Phase 3
Study Type Interventional
Primary Outcome
Measure Time Frame
Resolution Day 14 post-randomisation
Secondary Outcome
Measure Time Frame
Short-Term Resolution 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
Enrollment 500
Condition
Intervention

Intervention type: Other

Intervention name: Short-course Antibiotics

Description: 3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.

Arm group label: Catheter change+Short-course Antibiotics

Intervention type: Device

Intervention name: Catheter Change

Description: Urinary catheter change once randomization is complete.

Arm group label: Catheter change+Short-course Antibiotics

Eligibility

Criteria:

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.

Gender: All

Minimum age: 21 Years

Maximum age: N/A

Healthy volunteers: No

Overall Official
Last Name Role Affiliation
Paul A Tambyah, MD Principal Investigator National University Hospital, Singapore
Overall Contact

Last name: Paul A Tambyah, MD

Email: [email protected]

Location
facility status contact investigator
National University Hospital | Singapore, 119074, Singapore Recruiting Paul A Tambyah, MD [email protected] Paul A Tambyah, MD Principal Investigator
Singapore General Hospital | Singapore, 169608, Singapore Not yet recruiting Moi Lin Ling, FRCPA [email protected] Moi Lin Ling, FRCPA Principal Investigator
Tan Tock Seng Hospital | Singapore, 308433, Singapore Not yet recruiting David Lye, FRACP, FAMS [email protected] David Lye, FRACP, FAMS Principal Investigator
Location Countries

Singapore

Verification Date

January 2016

Responsible Party

Responsible party type: Sponsor

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 2
Arm Group

Arm group label: Control

Arm group type: No Intervention

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

Arm group label: Catheter change+Short-course Antibiotics

Arm group type: Experimental

Acronym CARCUTI
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Source: ClinicalTrials.gov