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Trial Outcomes & Findings for Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy (NCT NCT02247960)

NCT ID: NCT02247960

Last Updated: 2017-04-17

Results Overview

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.

Recruitment status

TERMINATED

Study phase

NA

Target enrollment

175 participants

Primary outcome timeframe

12 months

Results posted on

2017-04-17

Participant Flow

Participant milestones

Participant milestones
Measure
Ciprofloxacin
Antibiotic Ciprofloxacin
No Antibiotic
No Antibiotic
Patient Consent and Randomization
STARTED
85
90
Patient Consent and Randomization
COMPLETED
83
84
Patient Consent and Randomization
NOT COMPLETED
2
6
Catheter Removed
STARTED
83
84
Catheter Removed
COMPLETED
76
74
Catheter Removed
NOT COMPLETED
7
10

Reasons for withdrawal

Reasons for withdrawal
Measure
Ciprofloxacin
Antibiotic Ciprofloxacin
No Antibiotic
No Antibiotic
Patient Consent and Randomization
Physician Decision
2
2
Patient Consent and Randomization
Withdrawal by Subject
0
4
Catheter Removed
Lost to Follow-up
7
10

Baseline Characteristics

Antibiotic Prophylaxis for Urinary Catheter Removal After Radical Prostatectomy

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Ciprofloxacin
n=83 Participants
Antibiotic Ciprofloxacin
No Antibiotic
n=84 Participants
No Antibiotic
Total
n=167 Participants
Total of all reporting groups
Age, Continuous
62.49 years
STANDARD_DEVIATION 6.86 • n=93 Participants
62.98 years
STANDARD_DEVIATION 6.82 • n=4 Participants
62.8 years
STANDARD_DEVIATION 6.8 • n=27 Participants
Sex: Female, Male
Female
0 Participants
n=93 Participants
0 Participants
n=4 Participants
0 Participants
n=27 Participants
Sex: Female, Male
Male
83 Participants
n=93 Participants
84 Participants
n=4 Participants
167 Participants
n=27 Participants
Region of Enrollment
United States
83 participants
n=93 Participants
84 participants
n=4 Participants
167 participants
n=27 Participants

PRIMARY outcome

Timeframe: 12 months

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

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.

Outcome measures

Outcome measures
Measure
Ciprofloxacin
n=83 Participants
Antibiotic Ciprofloxacin
No Antibiotic
n=84 Participants
No Antibiotic
Number of Participants With a Positive Urinary Tract Infection
5 Participants
5 Participants

SECONDARY outcome

Timeframe: 3 months

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

Development of Clostridium difficile was measured in stool for clostridium difficile infection by enzyme immunoassay (EIA) and/or polymerase chain reaction (PCR).

Outcome measures

Outcome measures
Measure
Ciprofloxacin
n=83 Participants
Antibiotic Ciprofloxacin
No Antibiotic
n=84 Participants
No Antibiotic
Number of Participants Positive for Clostridium Difficile
0 Participants
3 Participants

SECONDARY outcome

Timeframe: 3 months

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

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.

Outcome measures

Outcome measures
Measure
Ciprofloxacin
n=73 Participants
Antibiotic Ciprofloxacin
No Antibiotic
n=84 Participants
No Antibiotic
Number of Participants With Bacteria in Urine
38 Participants
38 Participants

Adverse Events

Ciprofloxacin

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

No Antibiotic

Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Jean Joseph

University of Rochester

Phone: 585-341-7795

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place