Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

NCT02247960 | Terminated Results DMC

• 1 other identifier: RSRB#50607
• Study Type: interventional
• Target: 175
• Locations: 1 country
• Sites: 1

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.

Conditions

Prostate Cancer; Urinary Tract Infection; Clostridium Difficile

Outcome Measures

Primary Outcomes (1)

• 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.

  12 months

Secondary Outcomes (2)

• Number of Participants Positive for Clostridium Difficile

  3 months

• Number of Participants With Bacteria in Urine

  3 months

Study Arms (2)

Ciprofloxacin

ACTIVE COMPARATOR

Antibiotic

Drug: Ciprofloxacin

No Antibiotic

NO INTERVENTION

No Antibiotic

Interventions

Ciprofloxacin DRUG

Also known as: Cipro

Ciprofloxacin

Eligibility Criteria

• Age: 18 Years+
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects will include patients undergoing radical prostatectomy for prostate cancer. Subjects will be randomized into control or treatment group.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Rochester: lead

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

MeSH Terms

Conditions

Prostatic Neoplasms; Urinary Tract Infections

Interventions

Ciprofloxacin

Condition Hierarchy (Ancestors)

Genital Neoplasms, Male; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Genital Diseases, Male; Genital Diseases; Urogenital Diseases; Prostatic Diseases; Male Urogenital Diseases; Infections; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications

Intervention Hierarchy (Ancestors)

Fluoroquinolones; 4-Quinolones; Quinolones; Quinolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Jean Joseph
• Organization: University of Rochester

jean_joseph@urmc.rochester.edu

585-341-7795

Study Officials

• Jean V Joseph, M.D.

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Urology and Oncology

Study Record Dates

• First Submitted: August 29, 2014
• First Posted: September 25, 2014
• Study Start: July 1, 2014
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: April 17, 2017
• Results First Posted: March 15, 2017

Record last verified: 2017-03

Locations

US (1)