Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

Prostate Cancer Clinical Trial

— Abx  

Official title:

Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02247960
• Other study ID #: RSRB#50607
• Status: Terminated
• Phase: N/A
• First received: August 29, 2014
• Last updated: July 25, 2016
• Start date: July 2014
• Est. completion date: May 2016

Study information

• Verified date: July 2016
• Source: University of Rochester
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardUnited States: Data and Safety Monitoring BoardUnited States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 175
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Male
• Age group: 18 Years and older

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Clostridium Difficile
• Prostate Cancer
• Urinary Tract Infection
• Urinary Tract Infections

Intervention

Drug:
• Ciprofloxacin

Locations

Country	Name	City	State
United States	University of Rochester Medical Center	Rochester	New York

Sponsors (1)

Lead Sponsor	Collaborator
University of Rochester

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The metrics for resistant bacteria in the urine will be measured by urine culture.	Decrease in urinary tract infection following catheter removal in antibiotic group	At catheter removal and at the 3 month post-op visit.	Yes
Secondary	Development of Clostridium difficile will be measured as stool sample positive for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).		3 months	Yes
Secondary	Resistant bacteria in the urine		3 months	Yes
Secondary	Adverse events related to ciprofloxacin use		3 months	Yes