Clostridium Difficile, Prostate Cancer, Urinary Tract Infection
Conditions
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.
Interventions
DRUGCiprofloxacin
Sponsors
University of Rochester
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
MALE
Age
18 Years to No maximum
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ciprofloxacin Antibiotic
Ciprofloxacin | 83 |
| No Antibiotic No Antibiotic | 84 |
| Total | 167 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Catheter Removed | Lost to Follow-up | 7 | 10 |
| Patient Consent and Randomization | Physician Decision | 2 | 2 |
| Patient Consent and Randomization | Withdrawal by Subject | 0 | 4 |
Baseline characteristics
| Characteristic | Ciprofloxacin | No Antibiotic | Total |
|---|---|---|---|
| Age, Continuous | 62.49 years STANDARD_DEVIATION 6.86 | 62.98 years STANDARD_DEVIATION 6.82 | 62.8 years STANDARD_DEVIATION 6.8 |
| Region of Enrollment United States | 83 participants | 84 participants | 167 participants |
| Sex: Female, Male Female | 0 Participants | 0 Participants | 0 Participants |
| Sex: Female, Male Male | 83 Participants | 84 Participants | 167 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 83 | 0 / 84 |
| serious Total, serious adverse events | 0 / 83 | 0 / 84 |
Outcome results
Primary
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.
Time frame: 12 months
Population: this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ciprofloxacin | Number of Participants With a Positive Urinary Tract Infection | 5 Participants |
| No Antibiotic | Number of Participants With a Positive Urinary Tract Infection | 5 Participants |
p-value: 1Chi-squared
Secondary
Number of Participants Positive for Clostridium Difficile
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
Population: this outcome measure was only collected on patients who had their catheter removed (ie. started period 2)
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ciprofloxacin | Number of Participants Positive for Clostridium Difficile | 0 Participants |
| No Antibiotic | Number of Participants Positive for Clostridium Difficile | 3 Participants |
Secondary
Number of Participants With Bacteria in Urine
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
Population: 10 participants in the Ciprofloxacin arm and 16 participants in the no antibiotic arm did not have samples collected for testing.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ciprofloxacin | Number of Participants With Bacteria in Urine | 38 Participants |
| No Antibiotic | Number of Participants With Bacteria in Urine | 38 Participants |