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Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy (Abx)

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ClinicalTrials.gov Identifier: NCT02247960
Recruitment Status : Terminated (Interim analysis determined that the study should be concluded for futility.)
First Posted : September 25, 2014
Results First Posted : March 15, 2017
Last Update Posted : April 17, 2017
Sponsor:
Information provided by (Responsible Party):
Jean Joseph, University of Rochester

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.

Condition or disease Intervention/treatment Phase
Prostate Cancer Urinary Tract Infection Clostridium Difficile Drug: Ciprofloxacin Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 175 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy
Study Start Date : July 2014
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Ciprofloxacin
Antibiotic
Drug: Ciprofloxacin
Other Name: Cipro

No Intervention: No Antibiotic
No Antibiotic



Primary Outcome Measures :
  1. Number of Participants With a Positive Urinary Tract Infection [ Time Frame: 12 months ]
    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 :
  1. Number of Participants Positive for Clostridium Difficile [ Time Frame: 3 months ]
    Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).

  2. Number of Participants With Bacteria in Urine [ Time Frame: 3 months ]
    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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Male
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02247960


Locations
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United States, New York
University of Rochester Medical Center
Rochester, New York, United States, 14642
Sponsors and Collaborators
University of Rochester
Investigators
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Principal Investigator: Jean V Joseph, M.D. University of Rochester

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Responsible Party: Jean Joseph, Professor of Urology and Oncology, University of Rochester
ClinicalTrials.gov Identifier: NCT02247960     History of Changes
Other Study ID Numbers: RSRB#50607
First Posted: September 25, 2014    Key Record Dates
Results First Posted: March 15, 2017
Last Update Posted: April 17, 2017
Last Verified: March 2017
Additional relevant MeSH terms:
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Urinary Tract Infections
Infection
Urologic Diseases
Anti-Bacterial Agents
Ciprofloxacin
Antibiotics, Antitubercular
Anti-Infective Agents
Antitubercular Agents
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Cytochrome P-450 CYP1A2 Inhibitors
Cytochrome P-450 Enzyme Inhibitors