Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy (Abx)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|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
|Condition or disease||Intervention/treatment||Phase|
|Prostate Cancer Urinary Tract Infection Clostridium Difficile||Drug: Ciprofloxacin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||175 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
Active Comparator: Ciprofloxacin
Other Name: Cipro
No Intervention: No Antibiotic
- 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.
- 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).
- 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.
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
|United States, New York|
|University of Rochester Medical Center|
|Rochester, New York, United States, 14642|
|Principal Investigator:||Jean V Joseph, M.D.||University of Rochester|