Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections (CARCUTI)
Primary Purpose
Catheter-Related Infections
Status
Unknown status
Phase
Phase 2
Locations
Singapore
Study Type
Interventional
Intervention
Short-course Antibiotics
Catheter Change
Sponsored by
About this trial
This is an interventional treatment trial for Catheter-Related Infections focused on measuring Catheter-Associated Urinary Tract Infections, Antimicrobial Stewardship, Short-Course Antimicrobials
Eligibility Criteria
Inclusion Criteria:
- Inpatients ≥ 21 years old.
- Presence of indwelling urinary catheter at the time of urine culture for ≥2days.
- Fever >38°C.
- A urine specimen sent to the hospital microbiological laboratory for culture.
- An antibiotic order for presumed symptomatic catheter associated urinary tract infection.
Exclusion Criteria:
- Persistent fever >38°C for more than 24 hours, or any fever >38.9°C.
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
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
- New requirement for oxygen supplement.
- Current admission to a high dependency unit or ICU.
- Radiological evidence of an upper urinary tract infection
- Flank pain or tenderness, suggesting an upper urinary tract infection
- Urologic surgical procedure within the previous 72 hours
Known structural genitourinary abnormalities including:
- Nephrostomy tubes
- Tumours of the urinary tract
- Ureteric stenting
- Ureteric strictures
- Urolithiasis
- Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract.
- Received antibiotics for more than 48 hours prior to randomization.
- Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation.
- Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate.
- Pregnancy.
Sites / Locations
- National University HospitalRecruiting
- Singapore General Hospital
- Tan Tock Seng Hospital
Arms of the Study
Arm 1
Arm 2
Arm Type
No Intervention
Experimental
Arm Label
Control
Catheter change+Short-course Antibiotics
Arm Description
Subject receives the standard of care that is provided by the primary team taking up his/her case.
Outcomes
Primary Outcome Measures
Resolution
Resolution of signs and symptoms of CAUTI
Secondary Outcome Measures
Short-Term Resolution
Resolution of signs and symptoms of CAUTI
Recurrence of fever or symptoms
Haemodynamic instability
Admission to high dependency or intensive care units
Length of hospitalization
Re-admission
Secondary Infections
Recurrent Urinary Tract Infections
Urologic surgery or procedure
Antimicrobial use and duration
Colonization or infection by antibiotic-resistant organisms
Full Information
NCT ID
NCT02650518
First Posted
December 30, 2015
Last Updated
January 7, 2016
Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital, Singapore General Hospital, National University of Singapore
1. Study Identification
Unique Protocol Identification Number
NCT02650518
Brief Title
Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections
Acronym
CARCUTI
Official Title
Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections (CARCUTI)
Study Type
Interventional
2. Study Status
Record Verification Date
January 2016
Overall Recruitment Status
Unknown status
Study Start Date
December 2015 (undefined)
Primary Completion Date
October 2017 (Anticipated)
Study Completion Date
October 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
National University Hospital, Singapore
Collaborators
Tan Tock Seng Hospital, Singapore General Hospital, National University of Singapore
4. Oversight
Data Monitoring Committee
Yes
5. 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Catheter-Related Infections
Keywords
Catheter-Associated Urinary Tract Infections, Antimicrobial Stewardship, Short-Course Antimicrobials
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
500 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control
Arm Type
No Intervention
Arm Description
Subject receives the standard of care that is provided by the primary team taking up his/her case.
Arm Title
Catheter change+Short-course Antibiotics
Arm Type
Experimental
Intervention Type
Other
Intervention Name(s)
Short-course Antibiotics
Intervention Description
3 days of amoxicillin/clavulanate, ciprofloxacin, or cotrimoxazole.
Intervention Type
Device
Intervention Name(s)
Catheter Change
Intervention Description
Urinary catheter change once randomization is complete.
Primary Outcome Measure Information:
Title
Resolution
Description
Resolution of signs and symptoms of CAUTI
Time Frame
Day 14 post-randomisation
Secondary Outcome Measure Information:
Title
Short-Term Resolution
Description
Resolution of signs and symptoms of CAUTI
Time Frame
day 3 and day 7 post-randomisation
Title
Recurrence of fever or symptoms
Time Frame
7, 14 and 30 days post randomization
Title
Haemodynamic instability
Time Frame
day 14 post randomization
Title
Admission to high dependency or intensive care units
Time Frame
14 days post-randomization
Title
Length of hospitalization
Time Frame
30 days post-randomization
Title
Re-admission
Time Frame
Day 30 post-randomization
Title
Secondary Infections
Time Frame
3 months post-randomization
Title
Recurrent Urinary Tract Infections
Time Frame
3 months and 1 year post-randomization
Title
Urologic surgery or procedure
Time Frame
1 year post-randomization
Title
Antimicrobial use and duration
Time Frame
1 month post-randomization
Title
Colonization or infection by antibiotic-resistant organisms
Time Frame
30 days post-randomization
10. Eligibility
Sex
All
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Inpatients ≥ 21 years old.
Presence of indwelling urinary catheter at the time of urine culture for ≥2days.
Fever >38°C.
A urine specimen sent to the hospital microbiological laboratory for culture.
An antibiotic order for presumed symptomatic catheter associated urinary tract infection.
Exclusion Criteria:
Persistent fever >38°C for more than 24 hours, or any fever >38.9°C.
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
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
New requirement for oxygen supplement.
Current admission to a high dependency unit or ICU.
Radiological evidence of an upper urinary tract infection
Flank pain or tenderness, suggesting an upper urinary tract infection
Urologic surgical procedure within the previous 72 hours
Known structural genitourinary abnormalities including:
Nephrostomy tubes
Tumours of the urinary tract
Ureteric stenting
Ureteric strictures
Urolithiasis
Bloodstream or other significant infection suspected at any site other than the catheterized urinary tract.
Received antibiotics for more than 48 hours prior to randomization.
Positive urinary culture with organism resistant to all the investigational antibiotics in the week prior to randomisation.
Hypersensitivity to ciprofloxacin, cotrimoxazole and amoxicillin-clavulanate.
Pregnancy.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Paul A Tambyah, MD
Email
paul_anantharajah_tambyah@nuhs.edu.sg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Paul A Tambyah, MD
Organizational Affiliation
National University Hospital, Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
National University Hospital
City
Singapore
ZIP/Postal Code
119074
Country
Singapore
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paul A Tambyah, MD
Email
paul_anantharajah_tambyah@nuhs.edu.sg
First Name & Middle Initial & Last Name & Degree
Paul A Tambyah, MD
Facility Name
Singapore General Hospital
City
Singapore
ZIP/Postal Code
169608
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Moi Lin Ling, FRCPA
Email
ling.moi.lin@sgh.com.sg
First Name & Middle Initial & Last Name & Degree
Moi Lin Ling, FRCPA
Facility Name
Tan Tock Seng Hospital
City
Singapore
ZIP/Postal Code
308433
Country
Singapore
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
David Lye, FRACP, FAMS
Email
David_LYE@ttsh.com.sg
First Name & Middle Initial & Last Name & Degree
David Lye, FRACP, FAMS
12. IPD Sharing Statement
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Controlling Antimicrobial Use Through Reducing Unnecessary Treatment of Catheter Associated Urinary Tract Infections
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