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

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ClinicalTrials.gov Identifier: NCT02650518
Recruitment Status : Unknown
Verified January 2016 by National University Hospital, Singapore.
Recruitment status was:  Recruiting
First Posted : January 8, 2016
Last Update Posted : January 8, 2016
Sponsor:
Collaborators:
Tan Tock Seng Hospital
Singapore General Hospital
National University, Singapore
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Catheter-Related Infections Other: Short-course Antibiotics Device: Catheter Change Phase 2 Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated 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 : December 2015
Estimated Primary Completion Date : October 2017
Estimated Study Completion Date : October 2018

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Resolution [ Time Frame: Day 14 post-randomisation ]
    Resolution of signs and symptoms of CAUTI


Secondary Outcome Measures :
  1. Short-Term Resolution [ Time Frame: day 3 and day 7 post-randomisation ]
    Resolution of signs and symptoms of CAUTI

  2. Recurrence of fever or symptoms [ Time Frame: 7, 14 and 30 days post randomization ]
  3. Haemodynamic instability [ Time Frame: day 14 post randomization ]
  4. Admission to high dependency or intensive care units [ Time Frame: 14 days post-randomization ]
  5. Length of hospitalization [ Time Frame: 30 days post-randomization ]
  6. Re-admission [ Time Frame: Day 30 post-randomization ]
  7. Secondary Infections [ Time Frame: 3 months post-randomization ]
  8. Recurrent Urinary Tract Infections [ Time Frame: 3 months and 1 year post-randomization ]
  9. Urologic surgery or procedure [ Time Frame: 1 year post-randomization ]
  10. Antimicrobial use and duration [ Time Frame: 1 month post-randomization ]
  11. Colonization or infection by antibiotic-resistant organisms [ Time Frame: 30 days post-randomization ]


Information from the National Library of Medicine

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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02650518


Contacts
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Contact: Paul A Tambyah, MD paul_anantharajah_tambyah@nuhs.edu.sg

Locations
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Singapore
National University Hospital Recruiting
Singapore, Singapore, 119074
Contact: Paul A Tambyah, MD       paul_anantharajah_tambyah@nuhs.edu.sg   
Principal Investigator: Paul A Tambyah, MD         
Singapore General Hospital Not yet recruiting
Singapore, Singapore, 169608
Contact: Moi Lin Ling, FRCPA       ling.moi.lin@sgh.com.sg   
Principal Investigator: Moi Lin Ling, FRCPA         
Tan Tock Seng Hospital Not yet recruiting
Singapore, Singapore, 308433
Contact: David Lye, FRACP, FAMS       David_LYE@ttsh.com.sg   
Principal Investigator: David Lye, FRACP, FAMS         
Sponsors and Collaborators
National University Hospital, Singapore
Tan Tock Seng Hospital
Singapore General Hospital
National University, Singapore
Investigators
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Principal Investigator: Paul A Tambyah, MD National University Hospital, Singapore

Additional Information:
Publications:

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Responsible Party: National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT02650518     History of Changes
Other Study ID Numbers: 2014/00589
First Posted: January 8, 2016    Key Record Dates
Last Update Posted: January 8, 2016
Last Verified: January 2016
Keywords provided by National University Hospital, Singapore:
Catheter-Associated Urinary Tract Infections
Antimicrobial Stewardship
Short-Course Antimicrobials
Additional relevant MeSH terms:
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Infection
Communicable Diseases
Urinary Tract Infections
Catheter-Related Infections
Urologic Diseases
Anti-Bacterial Agents
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents