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

January 7, 2016 updated by: National University Hospital, Singapore

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

500

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Singapore
      • Singapore, Singapore, 169608
        • Not yet recruiting
        • Singapore General Hospital
        • Contact:
        • Principal Investigator:
          • Moi Lin Ling, FRCPA
      • Singapore, Singapore, 308433
        • Not yet recruiting
        • Tan Tock Seng Hospital
        • Contact:
        • Principal Investigator:
          • David Lye, FRACP, FAMS
      • Singapore, Singapore, 119074

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution
Time Frame: Day 14 post-randomisation
Resolution of signs and symptoms of CAUTI
Day 14 post-randomisation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Short-Term Resolution
Time Frame: day 3 and day 7 post-randomisation
Resolution of signs and symptoms of CAUTI
day 3 and day 7 post-randomisation
Recurrence of fever or symptoms
Time Frame: 7, 14 and 30 days post randomization
7, 14 and 30 days post randomization
Haemodynamic instability
Time Frame: day 14 post randomization
day 14 post randomization
Admission to high dependency or intensive care units
Time Frame: 14 days post-randomization
14 days post-randomization
Length of hospitalization
Time Frame: 30 days post-randomization
30 days post-randomization
Re-admission
Time Frame: Day 30 post-randomization
Day 30 post-randomization
Secondary Infections
Time Frame: 3 months post-randomization
3 months post-randomization
Recurrent Urinary Tract Infections
Time Frame: 3 months and 1 year post-randomization
3 months and 1 year post-randomization
Urologic surgery or procedure
Time Frame: 1 year post-randomization
1 year post-randomization
Antimicrobial use and duration
Time Frame: 1 month post-randomization
1 month post-randomization
Colonization or infection by antibiotic-resistant organisms
Time Frame: 30 days post-randomization
30 days post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National University Hospital, Singapore

Collaborators

Singapore General Hospital
Tan Tock Seng Hospital
National University of Singapore

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2015

Primary Completion (Anticipated)

October 1, 2017

Study Completion (Anticipated)

October 1, 2018

Study Registration Dates

First Submitted

December 30, 2015

First Submitted That Met QC Criteria

January 7, 2016

First Posted (Estimate)

January 8, 2016

Study Record Updates

Last Update Posted (Estimate)

January 8, 2016

Last Update Submitted That Met QC Criteria

January 7, 2016

Last Verified

January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2014/00589

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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