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

Sponsor
National University Hospital, Singapore (Other)
Overall Status
Unknown status
CT.gov ID
NCT02650518
Collaborator
Tan Tock Seng Hospital (Other), Singapore General Hospital (Other), National University, Singapore (Other)
500
Enrollment
3
Locations
2
Arms
34
Duration (Months)
166.7
Patients Per Site
4.9
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Short-course Antibiotics
  • Device: Catheter Change
 Phase 2/Phase 3

Study Design

Study Type:
Interventional
Anticipated Enrollment :
500 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
Official Title:
Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections (CARCUTI)
Study Start Date :
Dec 1, 2015
Anticipated Primary Completion Date :
Oct 1, 2017
Anticipated Study Completion Date :
Oct 1, 2018

Arms and Interventions

Arm Intervention/Treatment
No Intervention: Control

Subject receives the standard of care that is provided by the primary team taking up his/her case.
Experimental: Catheter change+Short-course Antibiotics

Other: Short-course Antibiotics
3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.

Device: Catheter Change
Urinary catheter change once randomization is complete.

Outcome Measures

Primary Outcome Measures

  1. Resolution [Day 14 post-randomisation]

    Resolution of signs and symptoms of CAUTI

Secondary Outcome Measures

  1. Short-Term Resolution [day 3 and day 7 post-randomisation]

    Resolution of signs and symptoms of CAUTI

  2. Recurrence of fever or symptoms [7, 14 and 30 days post randomization]

  3. Haemodynamic instability [day 14 post randomization]

  4. Admission to high dependency or intensive care units [14 days post-randomization]

  5. Length of hospitalization [30 days post-randomization]

  6. Re-admission [Day 30 post-randomization]

  7. Secondary Infections [3 months post-randomization]

  8. Recurrent Urinary Tract Infections [3 months and 1 year post-randomization]

  9. Urologic surgery or procedure [1 year post-randomization]

  10. Antimicrobial use and duration [1 month post-randomization]

  11. Colonization or infection by antibiotic-resistant organisms [30 days post-randomization]

Eligibility Criteria

Criteria

Ages Eligible for Study:
21 Years and Older
Sexes Eligible for Study:
All
Accepts 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

  1. 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

  1. New requirement for oxygen supplement.

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

  3. Radiological evidence of an upper urinary tract infection

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

  5. Urologic surgical procedure within the previous 72 hours

  6. Known structural genitourinary abnormalities including:

  • Nephrostomy tubes

  • Tumours of the urinary tract

  • Ureteric stenting

  • Ureteric strictures

  • Urolithiasis

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

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

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

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

  5. Pregnancy.

Contacts and Locations

Locations

Site City State Country Postal Code
1 National University Hospital Singapore Singapore 119074
2 Singapore General Hospital Singapore Singapore 169608
3 Tan Tock Seng Hospital Singapore Singapore 308433

Sponsors and Collaborators

  • National University Hospital, Singapore
  • Tan Tock Seng Hospital
  • Singapore General Hospital
  • National University, Singapore

Investigators

  • Principal Investigator: Paul A Tambyah, MD, National University Hospital, Singapore

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT02650518
Other Study ID Numbers:
  • 2014/00589
First Posted:
Jan 8, 2016
Last Update Posted:
Jan 8, 2016
Last Verified:
Jan 1, 2016
Keywords provided by National University Hospital, Singapore
Catheter-Associated Urinary Tract Infections
Antimicrobial Stewardship
Short-Course Antimicrobials
Additional relevant MeSH terms:
Infections
Communicable Diseases
Urinary Tract Infections
Catheter-Related Infections
Anti-Bacterial Agents

Study Results

No Results Posted as of Jan 8, 2016