Back to resultsAntibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy (Abx)
Primary Purpose
Prostate Cancer, Urinary Tract Infection, Clostridium Difficile
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Ciprofloxacin
Sponsored by
About this trial
This is an interventional treatment trial for Prostate Cancer
Eligibility Criteria
Inclusion Criteria:
- Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group.
Exclusion Criteria:
- Subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone will be excluded. Subjects being treated with tizanidine or with a history of myasthenia gravis will be excluded. In addition, we will exclude patients with major immediate post-operative complications after prostatectomy including significant post-operative bleeding with known pelvic hematoma and known urine leak.
Sites / Locations
- University of Rochester Medical Center
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Ciprofloxacin
No Antibiotic
Arm Description
Antibiotic
No Antibiotic
Outcomes
Primary Outcome Measures
Number of Participants With a Positive Urinary Tract Infection
After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.
Secondary Outcome Measures
Number of Participants Positive for Clostridium Difficile
Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).
Number of Participants With Bacteria in Urine
Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.
Full Information
NCT ID
NCT02247960
First Posted
August 29, 2014
Last Updated
March 17, 2017
Sponsor
University of Rochester
1. Study Identification
Unique Protocol Identification Number
NCT02247960
Brief Title
Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
Acronym
Abx
Official Title
Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
Study Type
Interventional
2. Study Status
Record Verification Date
March 2017
Overall Recruitment Status
Terminated
Why Stopped
Interim analysis determined that the study should be concluded for futility.
Study Start Date
July 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Rochester
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The aim of this study is to determine whether antibiotics prophylaxis at the time of urinary catheter removal decreases the number of symptomatic urinary tract infections in patients after radical prostatectomy. In addition, the investigators aim to determine whether antibiotic prophylaxis is potentially harmful to patients (e.g. adverse reactions from antibiotic use, resistant bacteria in the urine, Clostridium difficile infections etc.). The investigators also aim to identify specific populations that may be at higher risk of developing urinary tract infections with urinary catheter use after radical prostatectomy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prostate Cancer, Urinary Tract Infection, Clostridium Difficile
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
175 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ciprofloxacin
Arm Type
Active Comparator
Arm Description
Antibiotic
Arm Title
No Antibiotic
Arm Type
No Intervention
Arm Description
No Antibiotic
Intervention Type
Drug
Intervention Name(s)
Ciprofloxacin
Other Intervention Name(s)
Cipro
Primary Outcome Measure Information:
Title
Number of Participants With a Positive Urinary Tract Infection
Description
After removal of the catheter, urine was tested for infection whenever symptoms were experienced by the participants from the time they enrolled to 12 months following their operation.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Number of Participants Positive for Clostridium Difficile
Description
Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).
Time Frame
3 months
Title
Number of Participants With Bacteria in Urine
Description
Bacterial cultures were performed on urine and the presence of the following bacteria was determined: Acinetobacter, Coagulase-negative staphylococci, Diptherioids, Escherichia coli, Enterobacter, Enterococcus, Klebsiella pneumonia, and Lactoferrin. Participants who were positive for one or more of these were considered positive.
Time Frame
3 months
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group.
Exclusion Criteria:
Subjects with a history of adverse reaction to ciprofloxacin, or any other quinolone will be excluded. Subjects being treated with tizanidine or with a history of myasthenia gravis will be excluded. In addition, we will exclude patients with major immediate post-operative complications after prostatectomy including significant post-operative bleeding with known pelvic hematoma and known urine leak.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jean V Joseph, M.D.
Organizational Affiliation
University of Rochester
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Rochester Medical Center
City
Rochester
State/Province
New York
ZIP/Postal Code
14642
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
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