Abx: Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

• Sponsor: University of Rochester (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02247960
• Collaborator: (none)
• Enrollment: 175
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 8

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Prostate Cancer; Urinary Tract Infection; Clostridium Difficile	Drug: Ciprofloxacin	N/A

Study Design

• Study Type: Interventional
• 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: Jul 1, 2014
• Actual Primary Completion Date: May 1, 2016
• Actual Study Completion Date: May 1, 2016

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Ciprofloxacin Antibiotic	Drug: Ciprofloxacin; Other Names: Cipro
No Intervention: No Antibiotic No Antibiotic

Outcome Measures

Primary Outcome Measures

1. Number of Participants With a Positive Urinary Tract Infection [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: Male
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Rochester Medical Center	Rochester	New York	United States	14642

Sponsors and Collaborators

• University of Rochester

Investigators

• Principal Investigator: Jean V Joseph, M.D., University of Rochester

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Jean Joseph, Professor of Urology and Oncology, University of Rochester
• ClinicalTrials.gov Identifier: NCT02247960
• Other Study ID Numbers: RSRB#50607
• First Posted: Sep 25, 2014
• Last Update Posted: Apr 17, 2017
• Last Verified: Mar 1, 2017

• Additional relevant MeSH terms: Urinary Tract Infections; Ciprofloxacin

Study Results

Participant Flow

Arm/Group Title	Ciprofloxacin	No Antibiotic
Arm/Group Description	Antibiotic Ciprofloxacin	No Antibiotic
Period Title: Patient Consent and Randomization
STARTED	85	90
COMPLETED	83	84
NOT COMPLETED	2	6
Period Title: Patient Consent and Randomization
STARTED	83	84
COMPLETED	76	74
NOT COMPLETED	7	10

Baseline Characteristics

Arm/Group Title	Ciprofloxacin	No Antibiotic	Total
Arm/Group Description	Antibiotic Ciprofloxacin	No Antibiotic	Total of all reporting groups
Overall Participants	83	84	167
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	62.49 (6.86)	62.98 (6.82)	62.8 (6.8)
Sex: Female, Male (Count of Participants)
Female	0 0%	0 0%	0 0%
Male	83 100%	84 100%	167 100%
Region of Enrollment (participants) [Number]
United States	83 100%	84 100%	167 100%

Outcome Measures

1. Primary Outcome

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

Outcome Measure Data

Analysis Population Description

this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)

Arm/Group Title	Ciprofloxacin	No Antibiotic
Arm/Group Description	Antibiotic Ciprofloxacin	No Antibiotic
Measure Participants	83	84
Count of Participants [Participants]	5 6%	5 6%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Ciprofloxacin, No Antibiotic
	Comments
	Type of Statistical Test	Superiority or Other
	Comments
Statistical Test of Hypothesis	p-Value	1.00
	Comments
	Method	Chi-squared
	Comments

2. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)

Arm/Group Title	Ciprofloxacin	No Antibiotic
Arm/Group Description	Antibiotic Ciprofloxacin	No Antibiotic
Measure Participants	83	84
Count of Participants [Participants]	0 0%	3 3.6%

3. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

10 participants in the Ciprofloxacin arm and 16 participants in the no antibiotic arm did not have samples collected for testing.

Arm/Group Title	Ciprofloxacin	No Antibiotic
Arm/Group Description	Antibiotic Ciprofloxacin	No Antibiotic
Measure Participants	73	84
Count of Participants [Participants]	38 45.8%	38 45.2%

Adverse Events

Adverse Event Reporting Description	Adverse events were only collected on patients who had their catheter removed (ie. started period 2).
Arm/Group Title	Ciprofloxacin		No Antibiotic
Arm/Group Description	Antibiotic Ciprofloxacin		No Antibiotic
All Cause Mortality
	Ciprofloxacin		No Antibiotic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)
Serious Adverse Events
	Ciprofloxacin		No Antibiotic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/84 (0%)
Other (Not Including Serious) Adverse Events
	Ciprofloxacin		No Antibiotic
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/83 (0%)		0/84 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.