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Interim analysis determined that the study should be concluded for futility.
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Ciprofloxacin | Active Comparator | Antibiotic |
|
| No Antibiotic | No Intervention | No Antibiotic |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ciprofloxacin | Drug |
|
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | 3 months |
| Number of Participants With Bacteria in Urine |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jean V Joseph, M.D. | University of Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Rochester Medical Center | Rochester | New York | 14642 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | Ciprofloxacin | Antibiotic Ciprofloxacin |
| FG001 | No Antibiotic | No Antibiotic |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Patient Consent and Randomization |
|
| |||||||||||||||||||||
| Catheter Removed |
|
Baseline characteristics were only collected on patients who had their catheter removed (ie. started period 2).
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| ID | Title | Description |
|---|---|---|
| BG000 | Ciprofloxacin | Antibiotic Ciprofloxacin |
| BG001 | No Antibiotic | No Antibiotic |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | this outcome measure was only collected on patients who had their catheter removed (ie. started period 2) | Posted | Count of Participants | Participants | 12 months |
|
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Adverse events were only collected on patients who had their catheter removed (ie. started period 2).
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Ciprofloxacin | Antibiotic Ciprofloxacin |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Jean Joseph | University of Rochester | 585-341-7795 | jean_joseph@urmc.rochester.edu |
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| ID | Term |
|---|---|
| D011471 | Prostatic Neoplasms |
| D014552 | Urinary Tract Infections |
| ID | Term |
|---|---|
| D005834 | Genital Neoplasms, Male |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
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| ID | Term |
|---|---|
| D002939 | Ciprofloxacin |
| ID | Term |
|---|---|
| D024841 | Fluoroquinolones |
| D042462 | 4-Quinolones |
| D015363 | Quinolones |
| D011804 | Quinolines |
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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. |
| 3 months |
| NOT COMPLETED |
|
|
| BG002 |
| Total |
Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units | Counts |
|---|---|
| Participants |
|
|
|
| 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). | this outcome measure was only collected on patients who had their catheter removed (ie. started period 2) | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 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. | 10 participants in the Ciprofloxacin arm and 16 participants in the no antibiotic arm did not have samples collected for testing. | Posted | Count of Participants | Participants | 3 months |
|
|
|
| 0 |
| 83 |
| 0 |
| 83 |
| EG001 | No Antibiotic | No Antibiotic | 0 | 84 | 0 | 84 |
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| D005832 |
| Genital Diseases, Male |
| D000091662 | Genital Diseases |
| D000091642 | Urogenital Diseases |
| D011469 | Prostatic Diseases |
| D052801 | Male Urogenital Diseases |
| D007239 | Infections |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D006574 |
| Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D006571 | Heterocyclic Compounds |